metformin has been researched along with Body Weight in 680 studies
Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.
Body Weight: The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.
| Excerpt | Relevance | Reference |
|---|---|---|
| "In overweight or obese patients with T2DM, a once-weekly subcutaneous administration of PEG-Loxe for 16 weeks, in addition to lifestyle interventions or oral antidiabetic drug therapy, resulted in significantly greater weight loss compared to metformin." | 9.69 | Short-term effect of polyethylene glycol loxenatide on weight loss in overweight or obese patients with type 2 diabetes: An open-label, parallel-arm, randomized, metformin-controlled trial. ( Cai, H; Chen, Q; Duan, Y; Zhang, X; Zhao, Y, 2023) |
| "We aimed to determine the efficacy and safety of DDG combined with metformin for the treatment of T2DM patients with obesity." | 9.69 | Effectiveness and safety of Daixie Decoction granules combined with metformin for the treatment of T2DM patients with obesity: study protocol for a randomized, double-blinded, placebo-controlled, multicentre clinical trial. ( Liu, Z; Wang, F; Wang, L; Wang, M; Zhang, J; Zhang, K; Zhang, Y; Zhou, S; Zhou, Y, 2023) |
| "Here we study whether circulating GDF-15 levels were raised by such metformin treatment and whether they related to changes in body weight and visceral fat in children with obesity." | 9.51 | A 24-month metformin treatment study of children with obesity: Changes in circulating GDF-15 and associations with changes in body weight and visceral fat. ( Bassols, J; Carreras-Badosa, G; de Zegher, F; Díaz-Roldán, F; Gómez-Vilarrubla, A; Ibañez, L; López-Bermejo, A; Martínez-Calcerrada, JM; Mas-Parés, B; Prats-Puig, A; Puerto-Carranza, E; Xargay-Torrent, S, 2022) |
| "The glucose-lowering drug metformin has recently been shown to reduce myocardial oxygen consumption and increase myocardial efficiency in chronic heart failure (HF) patients without diabetes." | 9.41 | Metformin Lowers Body Weight But Fails to Increase Insulin Sensitivity in Chronic Heart Failure Patients without Diabetes: a Randomized, Double-Blind, Placebo-Controlled Study. ( Brøsen, K; Bøtker, HE; Dollerup, OL; Frøkiær, J; Hansson, NH; Jespersen, NR; Jessen, N; Larsen, AH; Møller, N; Nørrelund, H; Wiggers, H, 2021) |
| "Metformin treatment (1000-2000 mg/day) over 6 months in pubertal children and/or adolescents with obesity and hyperinsulinism is associated with a reduction in body mass index (BMI) and the insulin resistance index (HOMA-IR)." | 9.30 | Effects of metformin administration on endocrine-metabolic parameters, visceral adiposity and cardiovascular risk factors in children with obesity and risk markers for metabolic syndrome: A pilot study. ( Bassols, J; Carreras-Badosa, G; de Zegher, F; Díaz-Roldán, F; Dorado-Ceballos, E; Ibáñez, L; López-Bermejo, A; Martínez-Calcerrada, JM; Mas-Parés, B; Osiniri, I; Prats-Puig, A; Xargay-Torrent, S, 2019) |
| "This study provides evidence that, compared to glimepiride, saxagliptin more effectively achieves a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in T2D patients who are inadequately controlled with metformin monotherapy, especially in overweight patients with moderate hyperglycaemia and a relatively short duration of diabetes." | 9.30 | Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centr ( Bi, Y; Cheng, J; Gu, T; Li, D; Ma, J; Shao, J; Shi, B; Sun, Z; Xu, L; Zhang, H; Zhang, Q; Zhong, S; Zhu, D; Zhu, L, 2019) |
| "Metformin treatment significantly reduced LVMI, LVM, office systolic BP, body weight, and oxidative stress." | 9.30 | A randomized controlled trial of metformin on left ventricular hypertrophy in patients with coronary artery disease without diabetes: the MET-REMODEL trial. ( Al-Talabany, S; Baig, F; Bhalraam, U; Choy, AM; Gandy, SJ; George, J; Houston, JG; Hussain, MS; Khan, F; Lang, CC; Matthew, S; McKinnie, A; Mohan, M; Mordi, IR; Singh, JSS; Struthers, AD, 2019) |
| "This post hoc analysis assessed the effects on cardiovascular risk factors of body weight, systolic blood pressure (SBP) and triglycerides after 28 weeks' treatment with exenatide once weekly plus dapagliflozin, as compared with exenatide once weekly or dapagliflozin, in patient subpopulations from the DURATION-8 trial of patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone." | 9.27 | Effects of exenatide once weekly plus dapagliflozin, exenatide once weekly, or dapagliflozin, added to metformin monotherapy, on body weight, systolic blood pressure, and triglycerides in patients with type 2 diabetes in the DURATION-8 study. ( Ahmed, A; Frías, JP; Guja, C; Hardy, E; Jabbour, SA; Öhman, P, 2018) |
| " Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation." | 9.27 | CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine. ( Baker, A; Flaws, D; Friend, N; Kisely, S; Lim, C; McGrath, JJ; Moudgil, V; Patterson, S; Russell, A; Sardinha, S; Siskind, D; Stedman, T; Suetani, S; Winckel, K, 2018) |
| "Proof-of-concept study to investigate the amplifying effects of diazoxide (DZX)-mediated insulin suppression on lifestyle-induced weight loss in nondiabetic, hyperinsulinemic, obese men." | 9.27 | High-Dose, Diazoxide-Mediated Insulin Suppression Boosts Weight Loss Induced by Lifestyle Intervention. ( Brandon, T; de Boer, H; Filius, M; Hermus, A; Loves, S; Mekking, M; Tack, CJ; van Groningen, L, 2018) |
| "Steady-state population pharmacokinetics of a noncommercial immediate-release metformin (hydrochloride) drug product were characterized in 28 severely obese children with insulin resistance." | 9.24 | Effects of SLC22A1 Polymorphisms on Metformin-Induced Reductions in Adiposity and Metformin Pharmacokinetics in Obese Children With Insulin Resistance. ( Alfaro, RM; Calis, KA; Hon, YY; Reynolds, JC; Roza, O; Sam, WJ; Yanovski, JA, 2017) |
| " In this study, data were pooled from two randomized, placebo-controlled trials, which were originally designed to examine the efficacy of metformin in treating antipsychotic-induced weight gain and other metabolic abnormalities." | 9.22 | Metformin treatment of antipsychotic-induced dyslipidemia: an analysis of two randomized, placebo-controlled trials. ( Chan, PK; Gao, KM; Guo, WB; Jin, H; Ou, JJ; Shao, P; Wu, RR; Zhang, FY; Zhao, JP, 2016) |
| "Our results show that Metformin and acupuncture combined therapy significantly improves body weight, body mass index (BMI), fasting blood sugar (FBS), fasting insulin (FINS), homeostasis model assessment (HOMA) index, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), leptin, adiponectin, glucagon-like peptide-1 (GLP-1), resistin, serotonin, free fatty acids (FFAs), triglyceride (TG), low-density lipoprotein cholesterol (LDLc), high-density lipoprotein cholesterol (HDLc) and ceramides." | 9.22 | Comparative evaluation of the therapeutic effect of metformin monotherapy with metformin and acupuncture combined therapy on weight loss and insulin sensitivity in diabetic patients. ( Firouzjaei, A; Li, GC; Liu, WX; Wang, N; Zhu, BM, 2016) |
| "To evaluate the proportion of patients with type 2 diabetes mellitus (T2DM) achieving reductions in both glycated hemoglobin (HbA1c) and body weight with canagliflozin, a sodium glucose co-transporter 2 inhibitor, versus sitagliptin over 52 weeks." | 9.22 | Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes. ( Canovatchel, W; Davidson, JA; Jodon, H; Lavalle-González, FJ; Qiu, R; Schernthaner, G; Vijapurkar, U, 2016) |
| "The study will evaluate whether metformin can result in favorable changes in breast density, select proteins and hormones, products of body metabolism, and body weight and composition." | 9.22 | Phase II study of metformin for reduction of obesity-associated breast cancer risk: a randomized controlled trial protocol. ( Altbach, M; Chalasani, P; Chow, HH; Galons, JP; Martinez, JA; Roe, D; Stopeck, A; Thompson, PA; Thomson, CA; Villa-Guillen, DE, 2016) |
| "Metformin has been used for alleviating metabolic abnormalities in patients with schizophrenia." | 9.22 | Effects of Low Dose Metformin on Metabolic Traits in Clozapine-Treated Schizophrenia Patients: An Exploratory Twelve-Week Randomized, Double-Blind, Placebo-Controlled Study. ( Chen, CH; Chen, PY; Chiu, CC; Huang, MC; Lin, SK; Lin, YK; Lu, ML, 2016) |
| " This study was conducted as an exploratory analysis to clarify the effects of liraglutide, a GLP-1RA, on beta cell function, fat distribution and pancreas volume compared with metformin in Japanese overweight/obese patients with T2DM." | 9.20 | Effects of Liraglutide Monotherapy on Beta Cell Function and Pancreatic Enzymes Compared with Metformin in Japanese Overweight/Obese Patients with Type 2 Diabetes Mellitus: A Subpopulation Analysis of the KIND-LM Randomized Trial. ( Cobelli, C; Irie, J; Itoh, H; Jinzaki, M; Kawai, T; Manesso, E; Meguro, S; Saisho, Y; Sugiura, H; Tanaka, K; Tanaka, M, 2015) |
| "The effect of metformin on weight reduction in polycystic ovary syndrome (PCOS) is often unsatisfactory." | 9.19 | Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin. ( Janez, A; Jensterle Sever, M; Kocjan, T; Kravos, NA; Pfeifer, M, 2014) |
| "To study the effect of metformin on metabolic parameters, body weight (BW), and waist circumference (WC) in patients with abdominal obesity (AO)." | 9.19 | [Efficacy of metformin in abdominal obesity]. ( Kichigin, VA; Markova, TN; Mkrtumian, AM; Podachina, SV; Zhuchkova, SM, 2014) |
| "Many studies have shown that metformin can decrease body weight and improve metabolic abnormalities in patients with schizophrenia." | 9.17 | Effects of adjunctive metformin on metabolic traits in nondiabetic clozapine-treated patients with schizophrenia and the effect of metformin discontinuation on body weight: a 24-week, randomized, double-blind, placebo-controlled study. ( Chen, CH; Chiu, CC; Huang, MC; Kao, CF; Kuo, PH; Lin, SK; Lu, ML, 2013) |
| "Compared with metformin, exenatide is better to control blood glucose, reduces body weight and improves hepatic enzymes, attenuating NAFLD in patients with T2DM concomitant with NAFLD." | 9.17 | Exenatide improves type 2 diabetes concomitant with non-alcoholic fatty liver disease. ( Fan, H; Pan, Q; Xu, Y; Yang, X, 2013) |
| "We tested genetic associations with weight loss and weight regain in the Diabetes Prevention Program, a randomized controlled trial of weight loss-inducing interventions (lifestyle and metformin) versus placebo." | 9.16 | Genetic predictors of weight loss and weight regain after intensive lifestyle modification, metformin treatment, or standard care in the Diabetes Prevention Program. ( Delahanty, LM; Florez, JC; Franks, PW; Jablonski, KA; Kahn, SE; Knowler, WC; McCaffery, JM; Pan, Q; Shuldiner, A; Watson, KE, 2012) |
| " The body weight, body mass index, fasting insulin and insulin resistance index decreased significantly in the metformin group, but increased in the placebo group during the 12-week follow-up period." | 9.16 | Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study. ( Liang, GM; Tong, JH; Wang, M; Wang, XZ; Yan, HF; Zhu, G, 2012) |
| "Eighty-four women (ages 18-40 years) with first-episode schizophrenia who suffered from amenorrhea during antipsychotic treatment were randomly assigned, in a double-blind study design, to receive 1000 mg/day of metformin or placebo in addition to their antipsychotic treatment for 6 months." | 9.16 | Metformin for treatment of antipsychotic-induced amenorrhea and weight gain in women with first-episode schizophrenia: a double-blind, randomized, placebo-controlled study. ( Chan, PK; Davis, JM; Gao, K; Guo, XF; Jin, H; Ou, JJ; Shao, P; Twamley, EW; Wang, J; Wu, RR; Zhao, JP, 2012) |
| " This study aimed to determine the effect of metformin on body weight, body composition, metabolic risk factors and reproductive hormone levels in overweight or obese young women compared to placebo and comprehensive lifestyle intervention." | 9.15 | The effect of comprehensive lifestyle intervention or metformin on obesity in young women. ( Clifton, PM; Lim, SS; Noakes, M; Norman, RJ, 2011) |
| "Metformin had modest but favorable effects on body weight, body composition, and glucose homeostasis in obese insulin-resistant children participating in a low-intensity weight-reduction program." | 9.15 | Effects of metformin on body weight and body composition in obese insulin-resistant children: a randomized clinical trial. ( Brady, SM; Calis, KA; Kozlosky, M; Krakoff, J; McDuffie, JR; Reynolds, JC; Salaita, CG; Sebring, NG; Yanovski, JA, 2011) |
| "Comparing the effects of metformin or orlistat on hormone, lipid profile and ovulation status in obese women with polycystic ovary syndrome." | 9.15 | The effects of metformin or orlistat on obese women with polycystic ovary syndrome: a prospective randomized open-label study. ( Aflatoonian, A; Ghandi, S; Moghaddam, MH; Tabibnejad, N, 2011) |
| "The aim of this study was to evaluate the effect of exenatide compared to glimepiride on body weight, glycemic control and insulin resistance in type 2 diabetic patients taking metformin." | 9.15 | Exenatide or glimepiride added to metformin on metabolic control and on insulin resistance in type 2 diabetic patients. ( Bonaventura, A; Bossi, AC; Derosa, G; Fogari, E; Franzetti, IG; Guazzini, B; Maffioli, P; Putignano, P; Querci, F; Testori, G, 2011) |
| " Pioglitazone treatment (n = 10) reduced hepatic fat as assessed by magnetic resonance spectroscopy, despite a significant increase in body weight (Δ = 3." | 9.15 | Exenatide decreases hepatic fibroblast growth factor 21 resistance in non-alcoholic fatty liver disease in a mouse model of obesity and in a randomised controlled trial. ( Bajaj, M; Chan, L; Gonzalez, EV; Gutierrez, A; Jogi, M; Krishnamurthy, R; Muthupillai, R; Samson, SL; Sathyanarayana, P, 2011) |
| "The presence of fatty liver per ultrasound and liver-associated enzymes were measured in a select cohort of youth with both obesity and insulin resistance, and the effect of metformin on these parameters evaluated." | 9.14 | Treatment of non-alcoholic fatty liver disease with metformin versus lifestyle intervention in insulin-resistant adolescents. ( Ehlers, LB; Love-Osborne, K; Nadeau, KJ; Zeitler, PS, 2009) |
| "The aim of this study was to investigate the effects of pioglitazone or metformin on bone mass and atherosclerosis in patients with type 2 diabetes." | 9.14 | Baseline atherosclerosis parameter could assess the risk of bone loss during pioglitazone treatment in type 2 diabetes mellitus. ( Kanazawa, I; Kurioka, S; Sugimoto, T; Yamaguchi, T; Yamamoto, M; Yamauchi, M; Yano, S, 2010) |
| "Vildagliptin add-on has similar efficacy to glimepiride after 2 years' treatment, with markedly reduced hypoglycaemia risk and no weight gain." | 9.14 | Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study. ( Ahren, B; Couturier, A; Dejager, S; Ferrannini, E; Foley, JE; Fonseca, V; Matthews, DR; Zinman, B, 2010) |
| "One hundred forty-two nondiabetic women with polycystic ovary syndrome (PCOS) who had at least one live-birth (LB) pregnancy on metformin diet (172 pregnancies, 180 LBs)." | 9.13 | Prevention of gestational diabetes by metformin plus diet in patients with polycystic ovary syndrome. ( Aregawi, D; Glueck, CJ; Pranikoff, J; Wang, P, 2008) |
| "We evaluated exenatide (EX) and metformin (MET), alone and in combination (COM), on menstrual cyclicity, hormonal parameters, metabolic profiles, and inflammatory markers in overweight, insulin-resistant women with PCOS." | 9.13 | Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome. ( Bhushan, M; Bhushan, R; Elkind-Hirsch, K; Marrioneaux, O; Vernor, D, 2008) |
| "The present study aimed to investigate the effects of metformin on body weight in polycystic ovary syndrome (PCOS) patients by model-based meta-analysis (MBMA)." | 9.12 | Effects of metformin on body weight in polycystic ovary syndrome patients: model-based meta-analysis. ( Chen, X; He, S; Wang, D, 2021) |
| "This study was designed to assess the usefulness of a model-based index of insulin sensitivity during an oral glucose tolerance test (OGTT) in the identification of possible changes in this metabolic parameter produced by pharmacological agents known to be potent insulin sensitizers, that is metformin (M) and thiazolidinedione (T)." | 9.12 | Insulin sensitivity during oral glucose tolerance test and its relations to parameters of glucose metabolism and endothelial function in type 2 diabetic subjects under metformin and thiazolidinedione. ( Hanusch-Enserer, U; Kautzky-Willer, A; Ludvik, B; Pacini, G; Prager, R; Tura, A; Wagner, OF; Winzer, C, 2006) |
| "The authors hypothesized that a metformin (MET)-diet would improve symptoms of idiopathic intracranial hypertension (IIH) in women who also had polycystic ovary syndrome (PCOS) or hyperinsulinemia without PCOS." | 9.12 | Changes in weight, papilledema, headache, visual field, and life status in response to diet and metformin in women with idiopathic intracranial hypertension with and without concurrent polycystic ovary syndrome or hyperinsulinemia. ( Aregawi, D; Glueck, CJ; Goldenberg, N; Golnik, KC; Sieve, L; Wang, P, 2006) |
| "Metformin may safely assist olanzapine-treated patients in body weight and carbohydrate metabolism control." | 9.12 | Metformin as an adjunctive treatment to control body weight and metabolic dysfunction during olanzapine administration: a multicentric, double-blind, placebo-controlled trial. ( Baptista, T; Beaulieu, S; Carrizo, E; Connell, L; Dávila, A; de Baptista, EA; El Fakih, Y; Fernández, V; Galeazzi, T; Gutiérrez, MA; Rangel, N; Serrano, A; Servigna, M; Uzcátegui, E; Uzcátegui, M, 2007) |
| "The objective of the study was to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients." | 9.12 | Insulin sensitivity after metformin suspension in normal-weight women with polycystic ovary syndrome. ( De Feo, P; Falbo, A; Manguso, F; Orio, F; Palomba, S; Russo, T; Tolino, A; Zullo, F, 2007) |
| "65 kg/m(2)) hirsute women with polycystic ovary syndrome and normal insulin sensitivity were treated with 850 mg metformin orally, three times daily, for 4 months." | 9.12 | Metformin in normal-weight hirsute women with polycystic ovary syndrome with normal insulin sensitivity. ( Baracat, EC; Halpern, A; Maciel, GA; Marcondes, JA; Yamashita, SA, 2007) |
| "Our aim was to assess the effects of metformin on menstrual frequency, fasting plasma glucose (FPG), insulin resistance assessed as HOMA-index, weight, waist/hip ratio, blood pressure (BP), serum lipids, and testosterone levels in women with polycystic ovary syndrome (PCOS) METHODS: In a randomized, controlled, double-blinded setup, 56 women aged 18-45 with PCOS were treated with either metformin 850 mg or placebo twice daily for 6 months." | 9.12 | Efficacy of metformin in obese and non-obese women with polycystic ovary syndrome: a randomized, double-blinded, placebo-controlled cross-over trial. ( Flyvbjerg, A; Kesmodel, U; Lauszus, FF; Trolle, B, 2007) |
| " Objective To prospectively evaluate if administration of metformin to obese, diabetic patients with primary hypothyroidism on stable thyroxine replacement doses modifies TSH levels." | 9.12 | Metformin reduces thyrotropin levels in obese, diabetic women with primary hypothyroidism on thyroxine replacement therapy. ( Cordido, F; Isidro, ML; Nemiña, R; Penín, MA, 2007) |
| "To determine the clinical, hormonal, and biochemical effects of metformin therapy in obese and nonobese patients with polycystic ovary syndrome (PCOS)." | 9.11 | Nonobese women with polycystic ovary syndrome respond better than obese women to treatment with metformin. ( Abi Haidar, M; Alves da Motta, EL; Baracat, EC; de Lima, GR; Maciel, GA; Soares Júnior, JM, 2004) |
| "In a prospective observational study of 42 pregnancies in 39 Caucasian women (age 30 +/- 4 years) with polycystic ovary syndrome (PCOS), we examined effects of metformin on maternal insulin, insulin resistance (IR), insulin secretion (IS), weight gain, development of gestational diabetes (GD), testosterone and plasminogen activator inhibitor activity." | 9.11 | Metformin during pregnancy reduces insulin, insulin resistance, insulin secretion, weight, testosterone and development of gestational diabetes: prospective longitudinal assessment of women with polycystic ovary syndrome from preconception throughout preg ( Glueck, CJ; Goldenberg, N; Loftspring, M; Sherman, A; Wang, P, 2004) |
| "We prospectively assessed growth and motor-social development during the first 18 months of life in 126 live births (122 pregnancies) to 109 women with polycystic ovary syndrome (PCOS) who conceived on and continued metformin (1." | 9.11 | Height, weight, and motor-social development during the first 18 months of life in 126 infants born to 109 mothers with polycystic ovary syndrome who conceived on and continued metformin through pregnancy. ( Glueck, CJ; Goldenberg, N; Loftspring, M; Pranikoff, J; Sieve, L; Wang, P, 2004) |
| " metformin on the hormonal and biochemical features of patients with polycystic ovarian syndrome (PCOS)." | 9.11 | Orlistat is as beneficial as metformin in the treatment of polycystic ovarian syndrome. ( Atkin, SL; Holding, S; Jayagopal, V; Jennings, PE; Kilpatrick, ES, 2005) |
| " Although long-term treatment with metformin can increase Hcy levels in patients with type II diabetes mellitus or coronary heart disease, it is becoming an increasingly accepted and widespread medication in polycystic ovary syndrome (PCOS)." | 9.11 | Homocysteine levels in women with polycystic ovary syndrome treated with metformin versus rosiglitazone: a randomized study. ( Aslan, E; Bagis, T; Erkanli, S; Haydardedeoglu, B; Kilicdag, EB; Tarim, E; Zeyneloglu, HB, 2005) |
| "The aim of the current study was to assess the effects of B-group vitamins and folic acid administration on serum levels of homocysteine (Hcy) in patients with polycystic ovarian syndrome (PCOS) on short-term metformin treatment." | 9.11 | Administration of B-group vitamins reduces circulating homocysteine in polycystic ovarian syndrome patients treated with metformin: a randomized trial. ( Aslan, E; Bagis, T; Erkanli, S; Haydardedeoglu, B; Kilicdag, EB; Kuscu, E; Simsek, E; Tarim, E, 2005) |
| " The aim of this study was to assess the effects of rosiglitazone and metformin on cardiovascular disease risk factors such as insulin resistance, oxidative stress and homocysteine levels in lean patients with polycystic ovary syndrome (PCOS)." | 9.11 | The effects of rosiglitazone and metformin on oxidative stress and homocysteine levels in lean patients with polycystic ovary syndrome. ( Arslan, M; Ayvaz, G; Bukan, N; Cakir, N; Karakoç, A; Törüner, F; Yilmaz, M, 2005) |
| " There was a significant improvement in hirsutism at the end of the metformin phase compared with placebo: F-G score 15." | 9.10 | The effect of metformin on hirsutism in polycystic ovary syndrome. ( Gordon, D; Kelly, CJ, 2002) |
| "The results of this study confirm that sibutramine, orlistat and metformin are all effective and safe medications that reduce cardiovascular risk and can decrease the risk of type 2 diabetes mellitus in obese females." | 9.10 | Evaluation of the safety and efficacy of sibutramine, orlistat and metformin in the treatment of obesity. ( BascilTutuncu, N; Gokcel, A; Gumurdulu, Y; Guvener, N; Karakose, H; Melek Ertorer, E; Tanaci, N, 2002) |
| "To assess the effect of metformin on insulin sensitivity, glucose tolerance and components of the metabolic syndrome in patients with impaired glucose tolerance (IGT)." | 9.09 | Metabolic effects of metformin in patients with impaired glucose tolerance. ( Eriksson, JG; Forsén, B; Groop, L; Gullström, M; Häggblom, M; Lehtovirta, M; Taskinen, MR, 2001) |
| "Metformin lowered the LDL/HDL-cholesterol ratio by 12 and 6% at weeks 4 and 12, respectively, and reduced body weight by 1." | 9.08 | Metformin improves blood lipid pattern in nondiabetic patients with coronary heart disease. ( Bjerve, KS; Carlsen, SM; Følling, I; Rossvoll, O, 1996) |
| " Liraglutide is a glucagon-like peptide-1 receptor agonist that promotes sustained weight loss, as well as abdominal fat reduction, in individuals with obesity, prediabetes, and type 2 diabetes mellitus." | 9.05 | Liraglutide: New Perspectives for the Treatment of Polycystic Ovary Syndrome. ( Constantinidou, KG; Filippou, PK; Papaetis, GS; Stylianou, CS, 2020) |
| "We aimed to perform a meta-analysis of placebo-controlled studies investigating the body weight changes upon metformin treatment in participants older than 60 years." | 8.98 | Metformin induces significant reduction of body weight, total cholesterol and LDL levels in the elderly - A meta-analysis. ( Balaskó, M; Bérczi, B; Czopf, L; Garami, A; Gyöngyi, Z; Hartmann, P; Hegyi, P; Hussain, A; Ivic, I; Mátrai, P; Pétervári, E; Pótó, L; Sarlós, P; Simon, M; Solymár, M, 2018) |
| "In September 2018, we searched PubMed, Embase, and the Cochrane Library for studies published in English using the keywords metformin, obesity/overweight, and weight loss." | 8.98 | Efficacy of Metformin Treatment with Respect to Weight Reduction in Children and Adults with Obesity: A Systematic Review. ( Knibbe, CAJ; Lentferink, YE; van der Vorst, MMJ, 2018) |
| "We conducted a systematic-review and meta-analysis of metformin versus placebo for change in weight and metabolic syndrome for people on clozapine without diabetes mellitus." | 8.93 | Metformin for Clozapine Associated Obesity: A Systematic Review and Meta-Analysis. ( Kisely, S; Leung, J; Russell, AW; Siskind, DJ; Wysoczanski, D, 2016) |
| "Metformin, an oral anti-diabetic drug, is being considered increasingly for treatment and prevention of cancer, obesity as well as for the extension of healthy lifespan." | 8.88 | Metformin in obesity, cancer and aging: addressing controversies. ( Berstein, LM, 2012) |
| " While metformin has been shown to attenuate weight gain and insulin resistance, not all studies have shown a benefit in the reduction of antipsychotic-induced weight gain and insulin resistance." | 8.86 | The effect of metformin on anthropometrics and insulin resistance in patients receiving atypical antipsychotic agents: a meta-analysis. ( Coleman, CI; Ehret, M; Goethe, J; Lanosa, M, 2010) |
| "To assess the effectiveness of metformin in improving clinical and biochemical features of polycystic ovary syndrome." | 8.82 | Metformin in polycystic ovary syndrome: systematic review and meta-analysis. ( Flight, IH; Lord, JM; Norman, RJ, 2003) |
| "Metformin has become an established treatment for women with polycystic ovary syndrome, although controversy remains as to how effective it is and in which populations it should be used." | 8.82 | Metformin in polycystic ovary syndrome. ( Lord, J; Wilkin, T, 2004) |
| "Metformin, the most widely prescribed medication for obesity-associated type 2 diabetes (T2D), lowers plasma glucose levels, food intake, and body weight in rodents and humans, but the mechanistic site(s) of action remain elusive." | 8.31 | Metformin triggers a kidney GDF15-dependent area postrema axis to regulate food intake and body weight. ( Barros, DR; Bruce, K; Cherney, DZ; Chiu, JFM; Danaei, Z; Kuah, R; Lam, TKT; Li, RJW; Lim, YM; Mariani, LH; Reich, HN; Zhang, SY, 2023) |
| "We compared the efficacy and safety of beinaglutide, a glucagon-like peptide-1 (GLP-1) analogue with metformin in lowering the bodyweight of patients who were overweight/obese and non-diabetic." | 8.12 | Comparison of Beinaglutide Versus Metformin for Weight Loss in Overweight and Obese Non-diabetic Patients. ( Bi, Y; Feng, W; Fu, Y; Gao, L; Huang, H; Zhang, L; Zhang, N; Zhu, D, 2022) |
| "T2DM patients that performed regular exercise, had normal renal function and were receiving metformin were more likely to have clinically meaningful body weight reduction after one year treatment with dapagliflozin." | 8.12 | Predictors for successful weight reduction during treatment with Dapagliflozin among patients with type 2 diabetes mellitus in primary care. ( Huh, Y; Kim, YS, 2022) |
| "Linagliptin and its combination with metformin successfully ameliorated diabetic osteoporosis in HFD-fed mice possibly through modulation of BMP-2 and sclerostin." | 8.12 | Linagliptin in Combination With Metformin Ameliorates Diabetic Osteoporosis Through Modulating BMP-2 and Sclerostin in the High-Fat Diet Fed C57BL/6 Mice. ( Nirwan, N; Vohora, D, 2022) |
| " After metformin and exenatide supplementation, body weight, chow intake and ovarian morphology were observed." | 8.02 | Metformin and exenatide upregulate hepatocyte nuclear factor-4α, sex hormone binding globulin levels and improve hepatic triglyceride deposition in polycystic ovary syndrome with insulin resistance rats. ( He, B; Li, X; Lv, B; Wang, D; Xing, C; Zhao, H, 2021) |
| "The present study evaluated the effects of dapagliflozin, a SGLT2 inhibitor, or dapagliflozin plus metformin versus metformin monotherapy in patients with metabolic syndrome." | 8.02 | Dapagliflozin, metformin, monotherapy or both in patients with metabolic syndrome. ( Cheng, L; Fan, Y; Fu, Q; Lin, W; Liu, F; Wu, X; Zhang, X; Zhou, L, 2021) |
| " Metformin has potential effects on improving asthma airway inflammation." | 8.02 | Metformin alleviates allergic airway inflammation and increases Treg cells in obese asthma. ( Chen, M; Guo, Y; Hong, L; Jiang, S; Liu, S; Shi, J; Wang, Q; Yuan, X, 2021) |
| "To explore the effects of second-line combination therapies with metformin on body weight, HbA1c and health-related quality of life, as well as the risks of hypoglycaemia and further treatment intensification in the DISCOVER study, a 3-year, prospective, global observational study of patients with type 2 diabetes initiating second-line glucose-lowering therapy." | 8.02 | Associations between second-line glucose-lowering combination therapies with metformin and HbA1c, body weight, quality of life, hypoglycaemic events and glucose-lowering treatment intensification: The DISCOVER study. ( Charbonnel, B; Chen, H; Cooper, A; Gomes, MB; Ji, L; Khunti, K; Leigh, P; Nicolucci, A; Rathmann, W; Shestakova, MV; Siddiqui, A; Tang, F; Watada, H, 2021) |
| " Because previous data suggest the procognitive potential of the antidiabetic drug metformin, this study aimed to assess the effects of chronic clozapine and metformin oral administration (alone and in combination) on locomotor and exploratory activities and cognitive function in a reward-based test in control and a schizophrenia-like animal model (Wisket rats)." | 8.02 | Interaction of clozapine with metformin in a schizophrenia rat model. ( Adlan, LG; Benyhe, S; Büki, A; Heni, HE; Horvath, G; Kekesi, G; Kis, G; Szűcs, E, 2021) |
| "Metformin has been reported to decrease insulin resistance and is associated with a lower risk of pregnancy-induced hypertension and preeclampsia." | 7.91 | Effect of Metformin on a Preeclampsia-Like Mouse Model Induced by High-Fat Diet. ( Cao, G; Cao, X; Li, L; Wang, F; Yi, W, 2019) |
| "This study evaluated the preventative effects of metformin (Met) on glucocorticoid (GC)-induced osteoporosis in a rat model, compared with alendronate (Aln)." | 7.91 | Preventative effects of metformin on glucocorticoid-induced osteoporosis in rats. ( Li, Q; Li, Y; Meng, Y; Shi, D; Zhang, H; Zhao, J; Zuo, L, 2019) |
| "In diet-induced obesity, metformin (MF) has weight-lowering effect and improves glucose homeostasis and insulin sensitivity." | 7.91 | The evidence of metabolic-improving effect of metformin in Ay/a mice with genetically-induced melanocortin obesity and the contribution of hypothalamic mechanisms to this effect. ( Bakhtyukov, A; Bayunova, L; Derkach, K; Romanova, I; Shpakov, A; Zakharova, I; Zorina, I, 2019) |
| "Metformin treatment did not affect food intake, body weight, and casual blood glucose levels within each mouse line during the 20-week feeding period." | 7.91 | Metformin Attenuates Early-Stage Atherosclerosis in Mildly Hyperglycemic Oikawa-Nagao Mice. ( Asai, A; Kawahara, M; Miyazawa, T; Nagao, M; Oikawa, S; Shuto, Y; Sugihara, H, 2019) |
| "Metformin or/and α-LA attenuated the severity of the DSS-induced colitis through improving the reductions in body weights, the DAI, the colonic oxidative stress markers, TNF-α, and NF-κB levels, and the morphological mucosal damage scores." | 7.88 | New insights on the modulatory roles of metformin or alpha-lipoic acid versus their combination in dextran sulfate sodium-induced chronic colitis in rats. ( Elaidy, SM; Essawy, SS; Hassan, MS; Samman, FS, 2018) |
| "These data suggest that metformin protects against bleomycin-induced pulmonary fibrosis through activation of AMPK and amelioration of TGF-β signaling pathways." | 7.88 | Metformin alleviates bleomycin-induced pulmonary fibrosis in rats: Pharmacological effects and molecular mechanisms. ( Arava, S; Arya, DS; Bhatia, J; Gamad, N; Malik, S; Suchal, K; Tomar, A; Vasisht, S, 2018) |
| " Ursolic acid, metformin, gliclazide and their combinations when administered daily for 30 days significantly improved insulin sensitivity apart from behavioral and biochemical alterations in stressed mice." | 7.88 | Synergistic action of ursolic acid and metformin in experimental model of insulin resistance and related behavioral alterations. ( Ahuja, S; Akhtar, A; Kumar, A; Mourya, A; Sah, SP, 2018) |
| " In the present study, we investigated the potential therapeutic effects of metformin (Met) and saxagliptin (Saxa), as insulin sensitizing agents, in a rat model of brain aging and AD using D-galactose (D-gal, 150 mg/kg/day, s." | 7.85 | Involvement of insulin resistance in D-galactose-induced age-related dementia in rats: Protective role of metformin and saxagliptin. ( Attia, A; El-Shenawy, S; Gomaa, N; Hassan, A; Hegazy, R; Kenawy, S; Zaki, H, 2017) |
| " We evaluated whether obesity exacerbates progression of endometrial hyperplasia (EH) using the PRCre/+ PTENflox/+ mouse model and examined if the type 2 diabetes drug, metformin, could prevent EH." | 7.85 | Lean Body Weight and Metformin Are Insufficient to Prevent Endometrial Hyperplasia in Mice Harboring Inactivating Mutations in PTEN. ( Celestino, J; Iglesias, DA; Lu, KH; Schmandt, RE; Sun, CC; Yates, MS; Zhang, Q, 2017) |
| " In the present study, the effects of metformin on the development and recurrence of hepatocellular carcinoma (HCC) were investigated using the diethylnitrosamine (DEN)‑induced rat model of HCC." | 7.83 | Metformin inhibits early stage diethylnitrosamine‑induced hepatocarcinogenesis in rats. ( Chang, M; Choi, HJ; Jang, JJ; Jang, S; Jo, W; Lee, HJ; Park, HK; Ryu, JE; Son, WC; Yu, ES, 2016) |
| "Canagliflozin 100 and 300 mg provided sustained reductions in body weight, BMI, and waist circumference in a greater proportion of patients with T2DM versus glimepiride or placebo over 104 weeks." | 7.83 | Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. ( Blonde, L; Canovatchel, W; Fung, A; Meininger, G; Stenlöf, K; Xie, J, 2016) |
| "To investigate changes in body weight trajectories after the addition of individual sulphonylureas (SUs) to metformin in patients with type 2 diabetes." | 7.83 | Addition of sulphonylurea to metformin does not relevantly change body weight: a prospective observational cohort study (ZODIAC-39). ( Bilo, HJ; de Bock, GH; Groenier, KH; Houweling, ST; Kleefstra, N; Landman, GW; Schrijnders, D; van Hateren, KJ; Wever, R, 2016) |
| "We investigated the effects of metformin and celecoxib on obesity-induced adipose tissue inflammation, insulin resistance (IR), fatty liver, and high blood pressure in high-fat (HF) fed rats." | 7.83 | Additional effect of metformin and celecoxib against lipid dysregulation and adipose tissue inflammation in high-fat fed rats with insulin resistance and fatty liver. ( Hsieh, PS; Hung, YJ; Lu, CH, 2016) |
| " This study is to investigate the role of apoA5 in obesity-associated hypertriglyceridemia and metformin-related hypotriglyceridemic actions." | 7.83 | Metformin ameliorates obesity-associated hypertriglyceridemia in mice partly through the apolipoprotein A5 pathway. ( Chen, LZ; Huang, XS; Li, R; Zhao, SP; Zhao, W, 2016) |
| " In a post hoc meta-analysis of combined data from the 2 studies (n = 124), there was considerable overlapping in AUC(infinity) values between gender and race (Caucasians, Blacks, and Hispanics), making neither gender- nor racial-based dosing of pioglitazone or metformin necessary." | 7.82 | Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin. Effect of body weight, gender, and race on systemic exposures of each drug. ( Bradford, D; Cao, C; Karim, A; Laurent, A; Schwartz, L; Slater, M; Zhao, Z, 2007) |
| "To determine the effects of metformin therapy in children with metabolic syndrome (MS)." | 7.81 | Metformin treatment improves weight and dyslipidemia in children with metabolic syndrome. ( Ashraf, AP; Luong, DQ; Oster, R, 2015) |
| " We hypothesized that neonatal treatment with antidiabetic drug biguanide metformin would positively modify regulation of growth hormone--IGF-1--insulin signaling pathway slowing down aging and improving cancer preventive patterns in rodents." | 7.81 | Sex differences in aging, life span and spontaneous tumorigenesis in 129/Sv mice neonatally exposed to metformin. ( Anisimov, VN; Egormin, PA; Khaitsev, NV; Panchenko, AV; Popovich, IG; Semenchenko, AV; Trashkov, AP; Tyndyk, ML; Vasiliev, AG; Yurova, MN; Zabezhinski, MA, 2015) |
| " Metformin is a first-line treatment of type 2 diabetes, with minimal weight loss in humans." | 7.81 | Synergistic Effects of a GPR119 Agonist with Metformin on Weight Loss in Diet-Induced Obese Mice. ( Al-Barazanji, K; Benson, W; Binz, J; Chen, L; Generaux, C; McNulty, J; Young, A, 2015) |
| "Sixty six adult patients with schizophrenia or schizoaffective disorder treated, with atypical antipsychotics, and who had increased by more than 10% their pre treatment body weight, were randomly assigned to receive metformin or placebo in a double-blind study." | 7.81 | Metformin for treatment of antipsychotic-induced weight gain in a South Asian population with schizophrenia or schizoaffective disorder: A double blind, randomized, placebo controlled study. ( Dayabandara, M; de Silva, VA; Gunewardena, H; Hanwella, R; Henegama, T; Suraweera, C; Wijesundara, H, 2015) |
| "Metformin decreases polycystic ovary syndrome (PCOS) symptoms, induces ovulation, and may improve developmental competence of in vitro oocyte maturation." | 7.81 | Does metformin improve in vitro maturation and ultrastructure of oocytes retrieved from estradiol valerate polycystic ovary syndrome-induced rats. ( Mesbah, F; Mirkhani, H; Moslem, M; Vojdani, Z, 2015) |
| "The aim of our study was to assess the value of blood pressure and heart rate using the 24-hour blood pressure monitoring (ABPM) before and after treatment with metformin to patients with polycystic ovary syndrome (PCOS) and normal lean." | 7.81 | [Metformin and changes in blood pressure and heart rate in lean patients with polycystic ovary syndrome (PCOS)--preliminary study]. ( Kiałka, M; Klocek, M; Kowalczuk, A; Migacz, K; Milewicz, T; Ociepka, A; Tomczyk, R, 2015) |
| "In the present study, the ability of metformin to inhibit skin tumor promotion by 12-O-tetradecanoylphorbol-13-acetate (TPA) was analyzed in mice maintained on either an overweight control diet or an obesity-inducing diet." | 7.80 | Metformin inhibits skin tumor promotion in overweight and obese mice. ( Angel, JM; Beltran, L; Blando, J; Checkley, LA; Cho, J; DiGiovanni, J; Hursting, SD; Rho, O, 2014) |
| "Elevated asymmetric dimethylarginine (ADMA) levels and nitric oxide (NO) deficiency are associated with the development of hypertension." | 7.80 | Metformin reduces asymmetric dimethylarginine and prevents hypertension in spontaneously hypertensive rats. ( Hsu, CN; Huang, LT; Kuo, HC; Tain, YL; Tsai, CM, 2014) |
| "Metformin administration resulted in significant decrease in the body weight, body mass index, hirsutism score, fasting and postprandial blood glucose, fasting serum insulin, HOMA index, sleep disturbances scale, and Epworth sleepiness scale compared to the untreated PCOS group." | 7.80 | Effect of metformin on sleep disorders in adolescent girls with polycystic ovarian syndrome. ( Abdelmotaleb, GS; Aly, MK; El-Sharkawy, AA; Kabel, AM, 2014) |
| " At the end of the feeding schedule, Dia group had insulin resistance along with increased blood glucose, triglyceride, uric acid and nitric oxide (NO) levels." | 7.78 | Attenuation of insulin resistance, metabolic syndrome and hepatic oxidative stress by resveratrol in fructose-fed rats. ( Bagul, PK; Banerjee, SK; Bastia, T; Chakravarty, S; Madhusudana, K; Matapally, S; Middela, H; Padiya, R; Reddy, BR, 2012) |
| " We hypothesised that intervention with metformin would diminish the HF-feeding-evoked cognitive deficit by improving insulin sensitivity." | 7.78 | A high-fat-diet-induced cognitive deficit in rats that is not prevented by improving insulin sensitivity with metformin. ( Balfour, DJ; McNeilly, AD; Stewart, CA; Sutherland, C; Williamson, R, 2012) |
| "To define the pharmacogenetic features of the effect of metformin in coronary heart disease (CHD) patients with metabolic syndrome (MS) or type 2 diabetes mellitus (T2DM), by taking into consideration PPAR-gamma2 Pro1 2Ala polymorphism." | 7.78 | [Pharmacogenetic features of the effect of metformin in patients with coronary heart disease in the presence of metabolic syndrome and type 2 diabetes mellitus in terms of PPAR-gamma2 gene polymorphism]. ( Kaĭdashev, IP; Kutsenko, LA; Lavrenko, AV; Mamontova, TV; Shlykova, OA, 2012) |
| " The chronic treatment of inbred 129/Sv mice with metformin (100 mg/kg in drinking water) slightly modified the food consumption but failed to influence the dynamics of body weight, decreased by 13." | 7.76 | Gender differences in metformin effect on aging, life span and spontaneous tumorigenesis in 129/Sv mice. ( Anisimov, VN; Berstein, LM; Egormin, PA; Kovalenko, IG; Piskunova, TS; Popovich, IG; Poroshina, TE; Rosenfeld, SV; Semenchenko, AV; Tyndyk, ML; Yurova, MV; Zabezhinski, MA, 2010) |
| "Women with GDM treated with metformin and with similar baseline risk factors for adverse pregnancy outcomes had less weight gain and improved neonatal outcomes compared with those treated with insulin." | 7.75 | Pregnancy outcomes in women with gestational diabetes treated with metformin or insulin: a case-control study. ( Balani, J; Hyer, SL; Rodin, DA; Shehata, H, 2009) |
| " Here we show the chronic treatment of female outbred SHR mice with metformin (100 mg/kg in drinking water) slightly modified the food consumption but decreased the body weight after the age of 20 months, slowed down the age-related switch-off of estrous function, increased mean life span by 37." | 7.74 | Metformin slows down aging and extends life span of female SHR mice. ( Anisimov, VN; Berstein, LM; Egormin, PA; Kovalenko, IG; Piskunova, TS; Popovich, IG; Poroshina, TE; Semenchenko, AV; Tyndyk, ML; Yurova, MV; Zabezhinski, MA, 2008) |
| "The effect of 6 months of metformin treatment was prospectively assessed in 188 PCOS patients, divided into three groups according to body mass index (BMI; lean: BMI<25 kg/m2, overweight: BMI 25-29 kg/m2, and obese: BMI30 kg/m2)." | 7.74 | Metformin improves polycystic ovary syndrome symptoms irrespective of pre-treatment insulin resistance. ( Benson, S; Dietz, T; Elsenbruch, S; Hahn, S; Janssen, OE; Kimmig, R; Lahner, H; Mann, K; Moeller, LC; Schmidt, M; Tan, S, 2007) |
| "55 g/d for 28 weeks) would ameliorate morbid obesity and reduce centripetal obesity; lipid and lipoprotein cholesterol, insulin, and leptin levels; and plasminogen activator inhibitor activity (PAI-Fx), risk factors for coronary heart disease (CHD)." | 7.71 | Metformin reduces weight, centripetal obesity, insulin, leptin, and low-density lipoprotein cholesterol in nondiabetic, morbidly obese subjects with body mass index greater than 30. ( Fontaine, RN; Glueck, CJ; Illig, E; Lang, JE; McCullough, P; Sieve-Smith, L; Streicher, P; Subbiah, MT; Tracy, TM; Wang, P; Weber, K, 2001) |
| "To evaluate the long-term effects of metformin on biochemical variables and body weight in polycystic ovary syndrome (PCOS)." | 7.71 | Biochemical and body weight changes with metformin in polycystic ovary syndrome. ( Batukan, C; Batukan, M; Baysal, B, 2001) |
| "Before metformin therapy, after covariance adjustment for age, the two cohorts did not differ in height, weight, basal metabolic index, insulin, insulin resistance, or insulin secretion." | 7.71 | Metformin therapy throughout pregnancy reduces the development of gestational diabetes in women with polycystic ovary syndrome. ( Glueck, CJ; Kobayashi, S; Phillips, H; Sieve-Smith, L; Wang, P, 2002) |
| "HCl and metformin on diabetes and obesity were investigated in Wistar fatty rats, which are hyperglycaemic and hypertriglyceridaemic and have higher plasma levels of total ketone bodies than lean rats." | 7.71 | Effects of combined pioglitazone and metformin on diabetes and obesity in Wistar fatty rats. ( Ikeda, H; Odaka, H; Sugiyama, Y; Suzuki, M; Suzuki, N, 2002) |
| "To determine whether improvement of insulin resistance decreases blood pressure as well as obesity, metformin (100 mg/kg/d) or vehicle was administered for 20 weeks to 12-week-old male Otsuka Long-Evans Tokushima Fatty (OLETF) rats (n = 10 each), a newly developed animal model of non-insulin-dependent diabetes mellitus (NIDDM) with mild obesity, hyperinsulinemia, and hypertriglyceridemia." | 7.69 | Metformin decreases blood pressure and obesity in OLETF rats via improvement of insulin resistance. ( Inukai, K; Ishii, J; Kashiwabara, H; Katayama, S; Kikuchi, C; Kosegawa, I; Negishi, K; Oka, Y, 1996) |
| "Type 2 diabetes mellitus is closely related to nonalcoholic fatty liver disease(NAFLD)." | 6.94 | Liraglutide or insulin glargine treatments improves hepatic fat in obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks: A randomized placebo-controlled trial. ( Guo, W; Lin, L; Tian, W; Xu, X, 2020) |
| "Prediabetes is associated with increased prevalence of cardiovascular disease (CVD)." | 6.87 | Effect of intensive lifestyle modification & metformin on cardiovascular risk in prediabetes: A pilot randomized control trial. ( Bantwal, G; Fathima, S; George, B; Kulkarni, S; Umesh, S; Xavier, D, 2018) |
| "The objective of this study was to assess the efficacy and safety of metformin at the dosage of 2,500 mg/day in the treatment of obese women with PCOS and also to evaluate its effect on weight, hormones, and lipid profile." | 6.75 | Metformin 2,500 mg/day in the treatment of obese women with polycystic ovary syndrome and its effect on weight, hormones, and lipid profile. ( Aghahosseini, M; Aleyaseen, A; Kashani, L; Moddaress-Hashemi, S; Mofid, B; Safdarian, L, 2010) |
| "Liraglutide is a promising drug for the treatment of type 2 diabetes." | 6.72 | Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. ( Filipczak, R; Gumprecht, J; Hompesch, M; Le, TD; Nauck, MA; Zdravkovic, M, 2006) |
| "However, many antidiabetic treatments increase body weight." | 6.44 | Metformin and body weight. ( Golay, A, 2008) |
| "Metformin is a commonly used drug of PCOS but few studies on whether metformin can improve the follicle development and ovarian function in PCOS." | 5.91 | Metformin improves polycystic ovary syndrome in mice by inhibiting ovarian ferroptosis. ( Chang, Q; Chen, X; He, R; Hei, C; Li, G; Liang, X; Liu, H; Liu, X; Ouyang, J; Peng, Q; Ren, S; Sun, M; Sun, Y; Wang, C; Wang, Q; Wu, X; Xie, H, 2023) |
| "Metformin is a widely used drug for treating type 2 diabetes and is also used for delaying sexual maturation in girls with precocious puberty." | 5.72 | Metformin treatment of juvenile mice alters aging-related developmental and metabolic phenotypes. ( Bartke, A; Fang, Y; Medina, D; Yuan, R; Zhu, Y, 2022) |
| "Janagliflozin 25 or 50 mg once-daily added to metformin therapy significantly improved glycaemic control, reduced body weight and systolic blood pressure, improved high-density lipoprotein cholesterol and insulin sensitivity, and was generally well-tolerated by Chinese T2D patients who had poor glycaemic control with metformin monotherapy." | 5.69 | Efficacy and safety of janagliflozin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial. ( Chen, L; Chen, X; Cheng, Z; Gao, L; Guo, Y; Ji, L; Li, J; Liao, L; Pang, S; Song, W; Su, B; Su, X; Sun, J; Tan, X; Wang, K; Wang, Y; Xu, F; Ye, J, 2023) |
| "The Diabetes Prevention Program (DPP) and metformin can prevent or delay the onset of type 2 diabetes mellitus (T2DM) among patients with prediabetes." | 5.69 | Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change). ( Carter, EW; Heisler, M; Herman, WH; Kim, HM; Kullgren, JT; McEwen, LN; Resnicow, K; Rogers, B; Stoll, S; Vadari, HS; Volpp, KG, 2023) |
| "In overweight or obese patients with T2DM, a once-weekly subcutaneous administration of PEG-Loxe for 16 weeks, in addition to lifestyle interventions or oral antidiabetic drug therapy, resulted in significantly greater weight loss compared to metformin." | 5.69 | Short-term effect of polyethylene glycol loxenatide on weight loss in overweight or obese patients with type 2 diabetes: An open-label, parallel-arm, randomized, metformin-controlled trial. ( Cai, H; Chen, Q; Duan, Y; Zhang, X; Zhao, Y, 2023) |
| "We aimed to determine the efficacy and safety of DDG combined with metformin for the treatment of T2DM patients with obesity." | 5.69 | Effectiveness and safety of Daixie Decoction granules combined with metformin for the treatment of T2DM patients with obesity: study protocol for a randomized, double-blinded, placebo-controlled, multicentre clinical trial. ( Liu, Z; Wang, F; Wang, L; Wang, M; Zhang, J; Zhang, K; Zhang, Y; Zhou, S; Zhou, Y, 2023) |
| "The sitagliptin group receiving empagliflozin saw a substantial drop in HbA1c, fasting and postprandial plasma glucose levels, body weight, and blood pressure compared to the starting point." | 5.69 | Adding empagliflozin to sitagliptin plus metformin vs. adding sitagliptin to empagliflozin plus metformin as triple therapy in Egyptian patients with type 2 diabetes: a 12-week open trial. ( Ali, AM; Mostafa, MAA; Rabea, H; Salem, HF; Zakaraia, HG, 2023) |
| "A rat model of PCOS-IR was established using a high-fat diet (49 d) combined with letrozole (1 mg/kg·d, for 28 d)." | 5.62 | Effects of total flavonoids from Eucommia ulmoides Oliv. leaves on polycystic ovary syndrome with insulin resistance model rats induced by letrozole combined with a high-fat diet. ( Li, CX; Li, M; Miao, MS; Peng, MF; Ren, Z; Song, YG; Tian, S, 2021) |
| "Metformin is an antidiabetic drug commonly used in obesity treatment." | 5.56 | Effect of high-fat diet-induced obesity on thyroid gland structure in female rats and the possible ameliorating effect of metformin therapy. ( El-Sayed, SM; Ibrahim, HM, 2020) |
| "Rats treated with metformin showed a significant improvement in the aforementioned parameters." | 5.56 | Combined treatments with metformin and phosphodiesterase inhibitors alleviate nonalcoholic fatty liver disease in high-fat diet fed rats: a comparative study. ( Abdel-Latif, RG; El-Deen, RM; Heeba, GH; Khalifa, MMA, 2020) |
| "Twelve weeks of treatment with metformin resulted in a significant reduction in body weight and improved insulin sensitivity, but IHTG content and FA oxidation remained unchanged." | 5.51 | Metformin maintains intrahepatic triglyceride content through increased hepatic de novo lipogenesis. ( Charlton, C; Cornfield, T; Green, CJ; Hazlehurst, JM; Hodson, L; Marjot, T; McCullagh, J; Moolla, A; Pinnick, KE; Tomlinson, JW; Walsby-Tickle, J; Westcott, F, 2022) |
| "Here we study whether circulating GDF-15 levels were raised by such metformin treatment and whether they related to changes in body weight and visceral fat in children with obesity." | 5.51 | A 24-month metformin treatment study of children with obesity: Changes in circulating GDF-15 and associations with changes in body weight and visceral fat. ( Bassols, J; Carreras-Badosa, G; de Zegher, F; Díaz-Roldán, F; Gómez-Vilarrubla, A; Ibañez, L; López-Bermejo, A; Martínez-Calcerrada, JM; Mas-Parés, B; Prats-Puig, A; Puerto-Carranza, E; Xargay-Torrent, S, 2022) |
| "Polycystic ovary syndrome is one of the most common causes of female infertility, affecting 5-10% of the population." | 5.51 | Ocimum kilimandscharicum L. restores ovarian functions in letrozole - induced Polycystic Ovary Syndrome (PCOS) in rats: Comparison with metformin. ( AbdelMaksoud, S; El-Bahy, AA; Handoussa, H; Khaled, N; Radwan, R, 2019) |
| "Men with type 2 diabetes (T2D) and obesity are often characterised by low testosterone (T)." | 5.48 | Short-term combined treatment with exenatide and metformin is superior to glimepiride combined metformin in improvement of serum testosterone levels in type 2 diabetic patients with obesity. ( Hao, M; Kuang, HY; Li, BW; Ma, XF; Pan, J; Shao, N; Wu, WH; Yu, XY; Yu, YM; Zhang, HJ, 2018) |
| "Metformin was treated daily for 14 weeks in a high-fat dieting C57BL/6J mice." | 5.43 | Metformin Prevents Fatty Liver and Improves Balance of White/Brown Adipose in an Obesity Mouse Model by Inducing FGF21. ( Byun, JK; Cho, ML; Choi, JY; Jeong, JH; Jhun, JY; Kim, EK; Kim, JK; Lee, SH; Lee, SY, 2016) |
| "Metformin (Met), which is an insulin-sensitizer, decreases insulin resistance and fasting insulin levels." | 5.42 | Intracerebroventricular metformin decreases body weight but has pro-oxidant effects and decreases survival. ( Brochier, AW; de Assis, AM; de Carvalho, AK; Gnoatto, J; Haas, CB; Hansel, G; Muller, AP; Oses, JP; Portela, LV; Zimmer, ER, 2015) |
| "The metformin treatment of Wistar rats with obesity induced by high-fat diet was carried out for 2 months (daily dose of 200 mg/kg)." | 5.42 | [THE EFFECTS OF LONG-TERM METFORMIN TREATMENT ON THE ACTIVITY OF ADENYLYL CYCLASE SYSTEM AND NO-SYNTHASES IN THE BRAIN AND THE MYOCARDIUM OF RATS WITH OBESITY]. ( Bondareva, VM; Derkach, KV; Ignatieva, PA; Kuznetsova, LA; Sharova, TS; Shpakov, AO, 2015) |
| " The results showed that compared to dual therapy with DPP-4 inhibitor add-on to metformin, triple therapy with SGLT-2 inhibitor add-on to DPP-4 inhibitor plus metformin was associated with greater reductions in HbA1c, fasting blood glucose, postprandial blood glucose, body weight, and blood pressure (P < ." | 5.41 | Efficacy and Safety of Triple Therapy with SGLT-2 Inhibitor, DPP-4 Inhibitor, and Metformin in Type 2 Diabetes: A Meta-Analysis. ( Li, M; Wang, S; Wang, X, 2023) |
| "In conclusion, the administration of once-weekly Semaglutide exhibited a substantial reduction in HbA1c, average systolic blood pressure (SBP), mean diastolic blood pressure (DBP), body weight, waist circumference, body mass index (BMI), and a rise in pulse rate, as opposed to the once-daily administration of Sitagliptin." | 5.41 | Comparative efficacy and safety profile of once-weekly Semaglutide versus once-daily Sitagliptin as an add-on to metformin in patients with type 2 diabetes: a systematic review and meta-analysis. ( Ahmed, M; Butt, TS; Ganesan, S; Khatri, M; Kumar, S; Madhurita, F; Nageeta, F; Patel, T; Sohail, R; Varrassi, G; Zafar, M; Zafar, W; Zaman, MU, 2023) |
| "The glucose-lowering drug metformin has recently been shown to reduce myocardial oxygen consumption and increase myocardial efficiency in chronic heart failure (HF) patients without diabetes." | 5.41 | Metformin Lowers Body Weight But Fails to Increase Insulin Sensitivity in Chronic Heart Failure Patients without Diabetes: a Randomized, Double-Blind, Placebo-Controlled Study. ( Brøsen, K; Bøtker, HE; Dollerup, OL; Frøkiær, J; Hansson, NH; Jespersen, NR; Jessen, N; Larsen, AH; Møller, N; Nørrelund, H; Wiggers, H, 2021) |
| "These data suggest that the beneficial effects of liraglutide and sitagliptin on glucose metabolism, body weight and bile acids, when used as add-on therapies to metformin or sulphonylureas, are not linked to changes in the intestinal microbiota (NCT01744236)." | 5.41 | Liraglutide and sitagliptin have no effect on intestinal microbiota composition: A 12-week randomized placebo-controlled trial in adults with type 2 diabetes. ( Belzer, C; Cahen, DL; Davids, M; de Vos, WM; Fluitman, KS; Groen, AK; Herrema, H; Kramer, MHH; Nieuwdorp, M; Smits, MM; van Raalte, DH, 2021) |
| "Both bortezomib and metformin have been proposed as potential therapeutics in TSC." | 5.38 | Therapeutic trial of metformin and bortezomib in a mouse model of tuberous sclerosis complex (TSC). ( Auricchio, N; Kwiatkowski, DJ; Malinowska, I; Manning, BD; Shaw, R, 2012) |
| "Insulin resistance has been shown to be associated with cardiac sympathovagal imbalance, myocardial dysfunction, and cardiac mitochondrial dysfunction." | 5.38 | Cardioprotective effects of metformin and vildagliptin in adult rats with insulin resistance induced by a high-fat diet. ( Apaijai, N; Chattipakorn, N; Chattipakorn, SC; Pintana, H, 2012) |
| "Advanced HF (heart failure) is associated with altered substrate metabolism." | 5.37 | Effect of metformin therapy on cardiac function and survival in a volume-overload model of heart failure in rats. ( Benada, O; Benes, J; Cervenka, L; Drahota, Z; Houstek, J; Kazdova, L; Kolar, M; Kopecky, J; Kovarova, N; Medrikova, D; Melenovsky, V; Petrak, J; Sedmera, D; Skaroupkova, P; Strnad, H; Vrbacky, M, 2011) |
| "Metformin treatment also improved hyperleptinemia, whereas pioglitazone was ineffective." | 5.36 | Metformin reduces body weight gain and improves glucose intolerance in high-fat diet-fed C57BL/6J mice. ( Hirasawa, Y; Ito, M; Kyuki, K; Matsui, Y; Sugiura, T; Toyoshi, T, 2010) |
| "There is no known treatment for fatty liver, a ubiquitous cause of chronic liver disease." | 5.31 | Metformin reverses fatty liver disease in obese, leptin-deficient mice. ( Chuckaree, C; Diehl, AM; Kuhajda, F; Lin, HZ; Ronnet, G; Yang, SQ, 2000) |
| "Metformin treatment (1000-2000 mg/day) over 6 months in pubertal children and/or adolescents with obesity and hyperinsulinism is associated with a reduction in body mass index (BMI) and the insulin resistance index (HOMA-IR)." | 5.30 | Effects of metformin administration on endocrine-metabolic parameters, visceral adiposity and cardiovascular risk factors in children with obesity and risk markers for metabolic syndrome: A pilot study. ( Bassols, J; Carreras-Badosa, G; de Zegher, F; Díaz-Roldán, F; Dorado-Ceballos, E; Ibáñez, L; López-Bermejo, A; Martínez-Calcerrada, JM; Mas-Parés, B; Osiniri, I; Prats-Puig, A; Xargay-Torrent, S, 2019) |
| "This study provides evidence that, compared to glimepiride, saxagliptin more effectively achieves a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in T2D patients who are inadequately controlled with metformin monotherapy, especially in overweight patients with moderate hyperglycaemia and a relatively short duration of diabetes." | 5.30 | Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centr ( Bi, Y; Cheng, J; Gu, T; Li, D; Ma, J; Shao, J; Shi, B; Sun, Z; Xu, L; Zhang, H; Zhang, Q; Zhong, S; Zhu, D; Zhu, L, 2019) |
| " The objective of this study was to evaluate the effects of a triple combination of leucine, metformin, and sildenafil (NS-0200) on body weight and obesity comorbidities in a phase 2 randomized trial." | 5.30 | Randomized Controlled Trial of a Leucine-Metformin-Sildenafil Combination (NS-0200) on Weight and Metabolic Parameters. ( Barritt, AS; Chalasani, N; Flores, O; Kolterman, O; Rinella, M; Siddiqui, M; Vuppalanchi, R; Zemel, MB, 2019) |
| "Metformin treatment significantly reduced LVMI, LVM, office systolic BP, body weight, and oxidative stress." | 5.30 | A randomized controlled trial of metformin on left ventricular hypertrophy in patients with coronary artery disease without diabetes: the MET-REMODEL trial. ( Al-Talabany, S; Baig, F; Bhalraam, U; Choy, AM; Gandy, SJ; George, J; Houston, JG; Hussain, MS; Khan, F; Lang, CC; Matthew, S; McKinnie, A; Mohan, M; Mordi, IR; Singh, JSS; Struthers, AD, 2019) |
| "Metformin-treated rats gained significantly less weight." | 5.29 | Prevention of hyperglycemia in the Zucker diabetic fatty rat by treatment with metformin or troglitazone. ( Burant, CF; Polonsky, KS; Pugh, W; Sreenan, S; Sturis, J, 1996) |
| "This post hoc analysis assessed the effects on cardiovascular risk factors of body weight, systolic blood pressure (SBP) and triglycerides after 28 weeks' treatment with exenatide once weekly plus dapagliflozin, as compared with exenatide once weekly or dapagliflozin, in patient subpopulations from the DURATION-8 trial of patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone." | 5.27 | Effects of exenatide once weekly plus dapagliflozin, exenatide once weekly, or dapagliflozin, added to metformin monotherapy, on body weight, systolic blood pressure, and triglycerides in patients with type 2 diabetes in the DURATION-8 study. ( Ahmed, A; Frías, JP; Guja, C; Hardy, E; Jabbour, SA; Öhman, P, 2018) |
| " Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation." | 5.27 | CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine. ( Baker, A; Flaws, D; Friend, N; Kisely, S; Lim, C; McGrath, JJ; Moudgil, V; Patterson, S; Russell, A; Sardinha, S; Siskind, D; Stedman, T; Suetani, S; Winckel, K, 2018) |
| "Proof-of-concept study to investigate the amplifying effects of diazoxide (DZX)-mediated insulin suppression on lifestyle-induced weight loss in nondiabetic, hyperinsulinemic, obese men." | 5.27 | High-Dose, Diazoxide-Mediated Insulin Suppression Boosts Weight Loss Induced by Lifestyle Intervention. ( Brandon, T; de Boer, H; Filius, M; Hermus, A; Loves, S; Mekking, M; Tack, CJ; van Groningen, L, 2018) |
| "In Japanese patients with type 2 diabetes treated with vildagliptin and low-dose metformin, metformin up-titration significantly but modestly improved glycemic control without hypoglycemia and weight gain." | 5.24 | Safety and efficacy of metformin up-titration in Japanese patients with type 2 diabetes mellitus treated with vildagliptin and low-dose metformin. ( Azuma, K; Goto, H; Ikeda, F; Kanazawa, A; Komiya, K; Masuyama, A; Mita, T; Ogihara, T; Ohmura, C; Osonoi, T; Osonoi, Y; Saito, M; Sato, J; Shimizu, T; Someya, Y; Suzuki, L; Takayanagi, N; Takeno, K; Uzawa, H; Watada, H, 2017) |
| "Compared with glimepiride, Sita/Met as an initial treatment led to significantly greater improvements in glycemic control and body weight changes, with a lower incidence of hypoglycemia, over 30 weeks." | 5.24 | Efficacy and safety of sitagliptin/metformin fixed-dose combination compared with glimepiride in patients with type 2 diabetes: A multicenter randomized double-blind study. ( Chung, SC; Kim, IJ; Kim, SS; Kim, YI; Lee, KJ; Lee, SJ; Lee, YS; Park, JH, 2017) |
| "Steady-state population pharmacokinetics of a noncommercial immediate-release metformin (hydrochloride) drug product were characterized in 28 severely obese children with insulin resistance." | 5.24 | Effects of SLC22A1 Polymorphisms on Metformin-Induced Reductions in Adiposity and Metformin Pharmacokinetics in Obese Children With Insulin Resistance. ( Alfaro, RM; Calis, KA; Hon, YY; Reynolds, JC; Roza, O; Sam, WJ; Yanovski, JA, 2017) |
| "Liraglutide 3 mg was recently approved as an anti-obesity drug." | 5.24 | Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial. ( Goričar, K; Janez, A; Jensterle, M; Kravos, NA, 2017) |
| "Compared with metformin, vildagliptin combined with metformin could significantly reduce FPG, HbA1c and body weight." | 5.22 | Efficacy and safety of combination therapy with vildagliptin and metformin vs. metformin monotherapy for Type 2 Diabetes Mellitus therapy: a meta-analysis. ( Cao, L; Ding, Y; Dong, F; Li, Y; Lin, M; Lin, S; Liu, Y; Qu, Y, 2022) |
| "Changes from baseline in HbA1c, body weight, and systolic blood pressure (BP) with canagliflozin 100 and 300 mg versus placebo or active comparator (i." | 5.22 | Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. ( Alba, M; Cerdas, S; Chacon, Mdel P; Eliaschewitz, FG; Lavalle-González, FJ; Tong, C, 2016) |
| "Dapagliflozin, a highly selective sodium-glucose cotransporter 2 inhibitor, reduces hyperglycemia, body weight, and blood pressure in patients with type 2 diabetes (T2D)." | 5.22 | Efficacy and safety of dapagliflozin in Asian patients with type 2 diabetes after metformin failure: A randomized controlled trial. ( Han, P; Iqbal, N; Johnsson, E; Mansfield, T; Min, KW; Ptaszynska, A; T'Joen, C; Wang, B; Yang, W, 2016) |
| " In this study, data were pooled from two randomized, placebo-controlled trials, which were originally designed to examine the efficacy of metformin in treating antipsychotic-induced weight gain and other metabolic abnormalities." | 5.22 | Metformin treatment of antipsychotic-induced dyslipidemia: an analysis of two randomized, placebo-controlled trials. ( Chan, PK; Gao, KM; Guo, WB; Jin, H; Ou, JJ; Shao, P; Wu, RR; Zhang, FY; Zhao, JP, 2016) |
| "Liraglutide provided better glycaemic control and greater body weight reduction than sitagliptin when administered as add-on to metformin." | 5.22 | Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial. ( Bian, F; Bosch-Traberg, H; Geng, J; Li, Y; Liu, J; Liu, Y; Luo, Y; Lv, X; Mu, Y; Peng, Y; Sun, Y; Yang, J; Zang, L, 2016) |
| "Our results show that Metformin and acupuncture combined therapy significantly improves body weight, body mass index (BMI), fasting blood sugar (FBS), fasting insulin (FINS), homeostasis model assessment (HOMA) index, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), leptin, adiponectin, glucagon-like peptide-1 (GLP-1), resistin, serotonin, free fatty acids (FFAs), triglyceride (TG), low-density lipoprotein cholesterol (LDLc), high-density lipoprotein cholesterol (HDLc) and ceramides." | 5.22 | Comparative evaluation of the therapeutic effect of metformin monotherapy with metformin and acupuncture combined therapy on weight loss and insulin sensitivity in diabetic patients. ( Firouzjaei, A; Li, GC; Liu, WX; Wang, N; Zhu, BM, 2016) |
| "Titrated canagliflozin significantly improved HbA1c, FPG, body weight and SBP, and was generally well tolerated over 26 weeks in patients with T2DM as add-on to metformin and sitagliptin." | 5.22 | Efficacy and safety of titrated canagliflozin in patients with type 2 diabetes mellitus inadequately controlled on metformin and sitagliptin. ( Aggarwal, N; Alba, M; Cao, A; Fung, A; Pfeifer, M; Rodbard, HW; Seufert, J, 2016) |
| "To provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled on basal insulin glargine with or without 1-3 oral antidiabetic agents (OADs)." | 5.22 | Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. ( Aronson, R; Gentile, S; Guerci, B; Hanefeld, M; Heller, S; Perfetti, R; Rosenstock, J; Roy-Duval, C; Souhami, E; Tinahones, FJ; Wardecki, M; Ye, J, 2016) |
| "Subjects insufficiently controlled with sitagliptin who switch to liraglutide can obtain clinically relevant reductions in glycaemia and body weight, without compromising safety." | 5.22 | Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial. ( Bailey, TS; Kaltoft, MS; Maislos, M; Rao, PV; Takács, R; Thomsen, AB; Tinahones, FJ; Tsoukas, GM, 2016) |
| "We previously reported that dapagliflozin versus placebo as add-on to saxagliptin plus metformin resulted in greater reductions in glycated haemoglobin (A1C), fasting plasma glucose (FPG) and body weight (BW) after 24 weeks of treatment in patients with type 2 diabetes (T2D)." | 5.22 | Efficacy and safety of triple therapy with dapagliflozin add-on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes. ( Chen, H; Garcia-Sanchez, R; González González, JG; Hansen, L; Herrera Marmolejo, M; Iqbal, N; Johnsson, E; Mathieu, C, 2016) |
| "To evaluate the proportion of patients with type 2 diabetes mellitus (T2DM) achieving reductions in both glycated hemoglobin (HbA1c) and body weight with canagliflozin, a sodium glucose co-transporter 2 inhibitor, versus sitagliptin over 52 weeks." | 5.22 | Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes. ( Canovatchel, W; Davidson, JA; Jodon, H; Lavalle-González, FJ; Qiu, R; Schernthaner, G; Vijapurkar, U, 2016) |
| "Triple therapy with saxagliptin add-on to dapagliflozin plus metformin for 52 weeks resulted in sustained improvements in glycaemic control without an increase in body weight or increased risk of hypoglycaemia." | 5.22 | One-year efficacy and safety of saxagliptin add-on in patients receiving dapagliflozin and metformin. ( Aggarwal, N; Chen, H; Chin, A; Garcia-Hernandez, P; Hansen, L; Iqbal, N; Johnsson, E; Matthaei, S, 2016) |
| "The study will evaluate whether metformin can result in favorable changes in breast density, select proteins and hormones, products of body metabolism, and body weight and composition." | 5.22 | Phase II study of metformin for reduction of obesity-associated breast cancer risk: a randomized controlled trial protocol. ( Altbach, M; Chalasani, P; Chow, HH; Galons, JP; Martinez, JA; Roe, D; Stopeck, A; Thompson, PA; Thomson, CA; Villa-Guillen, DE, 2016) |
| "Metformin has been used for alleviating metabolic abnormalities in patients with schizophrenia." | 5.22 | Effects of Low Dose Metformin on Metabolic Traits in Clozapine-Treated Schizophrenia Patients: An Exploratory Twelve-Week Randomized, Double-Blind, Placebo-Controlled Study. ( Chen, CH; Chen, PY; Chiu, CC; Huang, MC; Lin, SK; Lin, YK; Lu, ML, 2016) |
| " Women were randomized to intensive lifestyle change (ILS) with the goals of weight reduction of at least 7% of initial weight and 150 min per week of moderate-intensity exercise, metformin 850 mg twice a day, or placebo administered twice a day." | 5.20 | Weight loss increases follicle stimulating hormone in overweight postmenopausal women [corrected]. ( Barrett-Connor, E; Golden, SH; Kim, C; Kong, S; Labrie, F; Nan, B; Randolph, JF, 2015) |
| "Canagliflozin improved glycaemic control, reduced body weight and systolic blood pressure, and was generally well tolerated in patients aged 55-80 years with T2DM over 104 weeks." | 5.20 | Long-term efficacy and safety of canagliflozin over 104 weeks in patients aged 55-80 years with type 2 diabetes. ( Bode, B; Fung, A; Harris, S; Meininger, G; Stenlöf, K; Sullivan, D; Usiskin, K, 2015) |
| "In patients completing 4 years of treatment, dapagliflozin was well tolerated and associated with sustained glycaemic efficacy and greater reductions in body weight and SBP versus glipizide." | 5.20 | Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. ( Del Prato, S; Durán-Garcia, S; Maffei, L; Nauck, M; Parikh, S; Rohwedder, K; Theuerkauf, A, 2015) |
| "Ertugliflozin (1-25 mg/day) improved glycaemic control, body weight and blood pressure in patients with T2DM suboptimally controlled on metformin, and was well tolerated." | 5.20 | Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. ( Amin, NB; Jain, SM; Lee, DS; Nucci, G; Rusnak, JM; Wang, X, 2015) |
| "Adding liraglutide to a basal insulin analogue ± metformin significantly improved glycaemic control, body weight and systolic blood pressure compared with placebo." | 5.20 | Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial. ( Ahmann, A; Boopalan, A; de Loredo, L; Lahtela, JT; Nauck, MA; Rodbard, HW; Rosenstock, J; Tornøe, K, 2015) |
| " This study was conducted as an exploratory analysis to clarify the effects of liraglutide, a GLP-1RA, on beta cell function, fat distribution and pancreas volume compared with metformin in Japanese overweight/obese patients with T2DM." | 5.20 | Effects of Liraglutide Monotherapy on Beta Cell Function and Pancreatic Enzymes Compared with Metformin in Japanese Overweight/Obese Patients with Type 2 Diabetes Mellitus: A Subpopulation Analysis of the KIND-LM Randomized Trial. ( Cobelli, C; Irie, J; Itoh, H; Jinzaki, M; Kawai, T; Manesso, E; Meguro, S; Saisho, Y; Sugiura, H; Tanaka, K; Tanaka, M, 2015) |
| "The effect of metformin on weight reduction in polycystic ovary syndrome (PCOS) is often unsatisfactory." | 5.19 | Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin. ( Janez, A; Jensterle Sever, M; Kocjan, T; Kravos, NA; Pfeifer, M, 2014) |
| "Roflumilast added to metformin reduced body weight in obese women with PCOS, primarily due to a loss of fat mass." | 5.19 | Phosphodiesterase 4 inhibition as a potential new therapeutic target in obese women with polycystic ovary syndrome. ( Janez, A; Jensterle, M; Kocjan, T, 2014) |
| "To study the effect of metformin on metabolic parameters, body weight (BW), and waist circumference (WC) in patients with abdominal obesity (AO)." | 5.19 | [Efficacy of metformin in abdominal obesity]. ( Kichigin, VA; Markova, TN; Mkrtumian, AM; Podachina, SV; Zhuchkova, SM, 2014) |
| " Patients also underwent a combined euglycemic, hyperinsulinemic, and hyperglycemic clamp with subsequent arginine stimulation to assess insulin sensitivity and insulin secretion." | 5.17 | Variation in inflammatory markers and glycemic parameters after 12 months of exenatide plus metformin treatment compared with metformin alone: a randomized placebo-controlled trial. ( Carbone, A; Ciccarelli, L; Derosa, G; Fogari, E; Franzetti, IG; Maffioli, P; Piccinni, MN; Querci, F, 2013) |
| "Many studies have shown that metformin can decrease body weight and improve metabolic abnormalities in patients with schizophrenia." | 5.17 | Effects of adjunctive metformin on metabolic traits in nondiabetic clozapine-treated patients with schizophrenia and the effect of metformin discontinuation on body weight: a 24-week, randomized, double-blind, placebo-controlled study. ( Chen, CH; Chiu, CC; Huang, MC; Kao, CF; Kuo, PH; Lin, SK; Lu, ML, 2013) |
| "Canagliflozin improved glycaemia and reduced body weight vs placebo (week 26) and sitagliptin (week 52) and was generally well tolerated in patients with type 2 diabetes on metformin." | 5.17 | Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. ( Canovatchel, W; Davidson, J; Januszewicz, A; Lavalle-González, FJ; Meininger, G; Qiu, R; Tong, C, 2013) |
| "The glucose-lowering efficiency of combination therapy with metformin + vildagliptin, a DPP-4 inhibitor, was comparable with that of a metformin + SU combination, but safer with respect to the risk of developing hypoglycemia." | 5.17 | [A combination of dipeptidyl peptidase-4 inhibitor and metformin in the treatment of patients with type 2 diabetes mellitus: effective control of glycemia, weight, and quantitative body composition]. ( Aleksandrov, AA; Chernova, TO; Dedov, II; Il'in, AV; Shestakova, MV; Shmushkovich, IA; Suhareva, OIu, 2013) |
| "Compared with metformin, exenatide is better to control blood glucose, reduces body weight and improves hepatic enzymes, attenuating NAFLD in patients with T2DM concomitant with NAFLD." | 5.17 | Exenatide improves type 2 diabetes concomitant with non-alcoholic fatty liver disease. ( Fan, H; Pan, Q; Xu, Y; Yang, X, 2013) |
| "These results show that in obese patients with type 2 diabetes, DPP-4 inhibitors treatment in combination with metformin was associated with improvements in glycaemic control, and a reduction in body weight." | 5.17 | The effects of dipeptidyl peptidase-4 inhibitors in treatment of obese patients with type 2 diabetes. ( Coric, J; Dizdarevic-Bostandzic, A; Djelilovic-Vranic, J; Izetbegovic, S; Karamehic, J; Macic-Dzankovic, A; Panjeta, M; Velija-Asimi, Z, 2013) |
| "In patients with type 2 diabetes, empagliflozin resulted in dose-dependent, clinically meaningful reductions in HbA1c and FPG, and reductions in body weight compared with placebo." | 5.17 | A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes. ( Ferrannini, E; Hantel, S; Pinnetti, S; Seewaldt-Becker, E; Seman, L; Woerle, HJ, 2013) |
| "We tested genetic associations with weight loss and weight regain in the Diabetes Prevention Program, a randomized controlled trial of weight loss-inducing interventions (lifestyle and metformin) versus placebo." | 5.16 | Genetic predictors of weight loss and weight regain after intensive lifestyle modification, metformin treatment, or standard care in the Diabetes Prevention Program. ( Delahanty, LM; Florez, JC; Franks, PW; Jablonski, KA; Kahn, SE; Knowler, WC; McCaffery, JM; Pan, Q; Shuldiner, A; Watson, KE, 2012) |
| " The body weight, body mass index, fasting insulin and insulin resistance index decreased significantly in the metformin group, but increased in the placebo group during the 12-week follow-up period." | 5.16 | Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study. ( Liang, GM; Tong, JH; Wang, M; Wang, XZ; Yan, HF; Zhu, G, 2012) |
| "Eighty-four women (ages 18-40 years) with first-episode schizophrenia who suffered from amenorrhea during antipsychotic treatment were randomly assigned, in a double-blind study design, to receive 1000 mg/day of metformin or placebo in addition to their antipsychotic treatment for 6 months." | 5.16 | Metformin for treatment of antipsychotic-induced amenorrhea and weight gain in women with first-episode schizophrenia: a double-blind, randomized, placebo-controlled study. ( Chan, PK; Davis, JM; Gao, K; Guo, XF; Jin, H; Ou, JJ; Shao, P; Twamley, EW; Wang, J; Wu, RR; Zhao, JP, 2012) |
| " This study aimed to determine the effect of metformin on body weight, body composition, metabolic risk factors and reproductive hormone levels in overweight or obese young women compared to placebo and comprehensive lifestyle intervention." | 5.15 | The effect of comprehensive lifestyle intervention or metformin on obesity in young women. ( Clifton, PM; Lim, SS; Noakes, M; Norman, RJ, 2011) |
| "Metformin had modest but favorable effects on body weight, body composition, and glucose homeostasis in obese insulin-resistant children participating in a low-intensity weight-reduction program." | 5.15 | Effects of metformin on body weight and body composition in obese insulin-resistant children: a randomized clinical trial. ( Brady, SM; Calis, KA; Kozlosky, M; Krakoff, J; McDuffie, JR; Reynolds, JC; Salaita, CG; Sebring, NG; Yanovski, JA, 2011) |
| "Comparing the effects of metformin or orlistat on hormone, lipid profile and ovulation status in obese women with polycystic ovary syndrome." | 5.15 | The effects of metformin or orlistat on obese women with polycystic ovary syndrome: a prospective randomized open-label study. ( Aflatoonian, A; Ghandi, S; Moghaddam, MH; Tabibnejad, N, 2011) |
| "The aim of this study was to evaluate the effect of exenatide compared to glimepiride on body weight, glycemic control and insulin resistance in type 2 diabetic patients taking metformin." | 5.15 | Exenatide or glimepiride added to metformin on metabolic control and on insulin resistance in type 2 diabetic patients. ( Bonaventura, A; Bossi, AC; Derosa, G; Fogari, E; Franzetti, IG; Guazzini, B; Maffioli, P; Putignano, P; Querci, F; Testori, G, 2011) |
| " Pioglitazone treatment (n = 10) reduced hepatic fat as assessed by magnetic resonance spectroscopy, despite a significant increase in body weight (Δ = 3." | 5.15 | Exenatide decreases hepatic fibroblast growth factor 21 resistance in non-alcoholic fatty liver disease in a mouse model of obesity and in a randomised controlled trial. ( Bajaj, M; Chan, L; Gonzalez, EV; Gutierrez, A; Jogi, M; Krishnamurthy, R; Muthupillai, R; Samson, SL; Sathyanarayana, P, 2011) |
| "The presence of fatty liver per ultrasound and liver-associated enzymes were measured in a select cohort of youth with both obesity and insulin resistance, and the effect of metformin on these parameters evaluated." | 5.14 | Treatment of non-alcoholic fatty liver disease with metformin versus lifestyle intervention in insulin-resistant adolescents. ( Ehlers, LB; Love-Osborne, K; Nadeau, KJ; Zeitler, PS, 2009) |
| "Addition of rosiglitazone to glucose-lowering therapy in people with type 2 diabetes is confirmed to increase the risk of heart failure and of some fractures, mainly in women." | 5.14 | Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. ( Beck-Nielsen, H; Curtis, PS; Gomis, R; Hanefeld, M; Home, PD; Jones, NP; Komajda, M; McMurray, JJ; Pocock, SJ, 2009) |
| " Vildagliptin provided additional HbA(1c) lowering to that achieved with metformin alone and comparable to that achieved with pioglitazone, with only pioglitazone causing weight gain." | 5.14 | Comparison of vildagliptin and pioglitazone in patients with type 2 diabetes inadequately controlled with metformin. ( Bolli, G; Colin, L; Dotta, F; Goodman, M; Minic, B, 2009) |
| "Clozapine is the most effective agent in treatment-resistant schizophrenia." | 5.14 | Extended release metformin for metabolic control assistance during prolonged clozapine administration: a 14 week, double-blind, parallel group, placebo-controlled study. ( Baptista, T; Carrizo, E; Connell, L; de Baptista, EA; Fernández, I; Fernández, V; Mogollón, J; Prieto, D; Sandia, I; Valbuena, D, 2009) |
| "The aim of the study was to compare the effects of the addition of sitagliptin or metformin to pioglitazone monotherapy in poorly controlled type 2 diabetes mellitus patients on body weight, glycemic control, beta-cell function, insulin resistance, and inflammatory state parameters." | 5.14 | Effects of sitagliptin or metformin added to pioglitazone monotherapy in poorly controlled type 2 diabetes mellitus patients. ( Ciccarelli, L; Cicero, AF; D'Angelo, A; Derosa, G; Ferrari, I; Franzetti, IG; Gadaleta, G; Maffioli, P; Piccinni, MN; Querci, F; Ragonesi, PD; Salvadeo, SA, 2010) |
| "The aim of this study was to investigate the effects of pioglitazone or metformin on bone mass and atherosclerosis in patients with type 2 diabetes." | 5.14 | Baseline atherosclerosis parameter could assess the risk of bone loss during pioglitazone treatment in type 2 diabetes mellitus. ( Kanazawa, I; Kurioka, S; Sugimoto, T; Yamaguchi, T; Yamamoto, M; Yamauchi, M; Yano, S, 2010) |
| " The aim of our study was to evaluate the effects of exenatide compared to glibenclamide on body weight, glycemic control, beta-cell function, insulin resistance, and inflammatory state in patients with diabetes." | 5.14 | Exenatide versus glibenclamide in patients with diabetes. ( Ciccarelli, L; Cicero, AF; D'Angelo, A; Derosa, G; Ferrari, I; Franzetti, IG; Gadaleta, G; Maffioli, P; Piccinni, MN; Querci, F; Ragonesi, PD; Salvadeo, SA, 2010) |
| "Pioglitazone was associated with a rapid increase in body weight and an increase in diurnal proximal sodium reabsorption, without any change in renal haemodynamics or in the modulation of the renin-angiotensin aldosterone system to changes in salt intake." | 5.14 | Effects of the peroxisome proliferator-activated receptor (PPAR)-gamma agonist pioglitazone on renal and hormonal responses to salt in diabetic and hypertensive individuals. ( Burnier, M; Deleaval, P; Jornayvaz, FR; Maillard, M; Nussberger, J; Pechere-Bertschi, A; Vinciguerra, M; Zanchi, A, 2010) |
| "Obese European adolescents' insulin sensitivity improved without weight change during placebo or metformin intervention in addition to lifestyle intervention." | 5.14 | Metformin and placebo therapy both improve weight management and fasting insulin in obese insulin-resistant adolescents: a prospective, placebo-controlled, randomized study. ( Bürmann, M; Grüters, A; Holl, RW; Hübel, H; Krude, H; l'Allemand, D; Martus, P; Wiegand, S, 2010) |
| "Vildagliptin add-on has similar efficacy to glimepiride after 2 years' treatment, with markedly reduced hypoglycaemia risk and no weight gain." | 5.14 | Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study. ( Ahren, B; Couturier, A; Dejager, S; Ferrannini, E; Foley, JE; Fonseca, V; Matthews, DR; Zinman, B, 2010) |
| "To determine whether metformin treatment for 6 months is effective in reducing body weight and hyperinsulinemia and also ameliorating insulin sensitivity indices in obese adolescents with hyperinsulinemia." | 5.13 | Use of metformin in obese adolescents with hyperinsulinemia: a 6-month, randomized, double-blind, placebo-controlled clinical trial. ( Atabek, ME; Pirgon, O, 2008) |
| "Metformin was reported to improve the alterations of endothelial reactivity in normal-weight subjects with polycystic ovary syndrome (PCOS)." | 5.13 | Metformin improves endothelial function in normoinsulinemic PCOS patients: a new prospective. ( Bompiani, A; Costantini, B; Cristello, F; Giuliani, M; Guido, M; Lanzone, A; Macrì, F; Romualdi, D; Selvaggi, L, 2008) |
| "One hundred forty-two nondiabetic women with polycystic ovary syndrome (PCOS) who had at least one live-birth (LB) pregnancy on metformin diet (172 pregnancies, 180 LBs)." | 5.13 | Prevention of gestational diabetes by metformin plus diet in patients with polycystic ovary syndrome. ( Aregawi, D; Glueck, CJ; Pranikoff, J; Wang, P, 2008) |
| "The second generation antipsychotic drugs, such as risperidone, olanzapine, and quetiapine, are effective in treating patients with schizophrenia and have been considered as the first line therapy." | 5.13 | Metformin for metabolic dysregulation in schizophrenic patients treated with olanzapine. ( Chen, CH; Chiu, CC; Huang, MC; Liu, HC; Lu, ML; Wu, TH, 2008) |
| "Effects of metformin and pioglitazone on body weight are clearly different." | 5.13 | Metformin, but not pioglitazone, decreases postchallenge plasma ghrelin levels in type 2 diabetic patients: a possible role in weight stability? ( Horie, H; Ishibashi, S; Kusaka, I; Nagasaka, S, 2008) |
| "To investigate the effects of extended-release metformin (MXR) compared with immediate-release metformin (MIR) on post-prandial glycaemic excursion, chronic glycaemia, lipid profiles, insulin resistance and islet function in type 2 diabetes." | 5.13 | The metabolic effects of once daily extended-release metformin in patients with type 2 diabetes: a multicentre study. ( Gao, H; Hong, T; Wang, C; Xiao, W; Yang, J; Yang, W; Yang, Y; Zhang, J, 2008) |
| "We evaluated exenatide (EX) and metformin (MET), alone and in combination (COM), on menstrual cyclicity, hormonal parameters, metabolic profiles, and inflammatory markers in overweight, insulin-resistant women with PCOS." | 5.13 | Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome. ( Bhushan, M; Bhushan, R; Elkind-Hirsch, K; Marrioneaux, O; Vernor, D, 2008) |
| "The present study aimed to investigate the effects of metformin on body weight in polycystic ovary syndrome (PCOS) patients by model-based meta-analysis (MBMA)." | 5.12 | Effects of metformin on body weight in polycystic ovary syndrome patients: model-based meta-analysis. ( Chen, X; He, S; Wang, D, 2021) |
| "This study was designed to assess the usefulness of a model-based index of insulin sensitivity during an oral glucose tolerance test (OGTT) in the identification of possible changes in this metabolic parameter produced by pharmacological agents known to be potent insulin sensitizers, that is metformin (M) and thiazolidinedione (T)." | 5.12 | Insulin sensitivity during oral glucose tolerance test and its relations to parameters of glucose metabolism and endothelial function in type 2 diabetic subjects under metformin and thiazolidinedione. ( Hanusch-Enserer, U; Kautzky-Willer, A; Ludvik, B; Pacini, G; Prager, R; Tura, A; Wagner, OF; Winzer, C, 2006) |
| "The authors hypothesized that a metformin (MET)-diet would improve symptoms of idiopathic intracranial hypertension (IIH) in women who also had polycystic ovary syndrome (PCOS) or hyperinsulinemia without PCOS." | 5.12 | Changes in weight, papilledema, headache, visual field, and life status in response to diet and metformin in women with idiopathic intracranial hypertension with and without concurrent polycystic ovary syndrome or hyperinsulinemia. ( Aregawi, D; Glueck, CJ; Goldenberg, N; Golnik, KC; Sieve, L; Wang, P, 2006) |
| " However, body weight, waist circumference, fasting serum levels of insulin and C-peptide were lower and less number of patients experienced hypoglycaemia during treatment with metformin vs." | 5.12 | Targeting hyperglycaemia with either metformin or repaglinide in non-obese patients with type 2 diabetes: results from a randomized crossover trial. ( Frandsen, M; Lund, SS; Parving, HH; Pedersen, O; Schalkwijk, CG; Smidt, UM; Stehouwer, CD; Tarnow, L; Vaag, A, 2007) |
| "Metformin may safely assist olanzapine-treated patients in body weight and carbohydrate metabolism control." | 5.12 | Metformin as an adjunctive treatment to control body weight and metabolic dysfunction during olanzapine administration: a multicentric, double-blind, placebo-controlled trial. ( Baptista, T; Beaulieu, S; Carrizo, E; Connell, L; Dávila, A; de Baptista, EA; El Fakih, Y; Fernández, V; Galeazzi, T; Gutiérrez, MA; Rangel, N; Serrano, A; Servigna, M; Uzcátegui, E; Uzcátegui, M, 2007) |
| "The objective of the study was to evaluate the effects of metformin suspension on insulin sensitivity in PCOS patients." | 5.12 | Insulin sensitivity after metformin suspension in normal-weight women with polycystic ovary syndrome. ( De Feo, P; Falbo, A; Manguso, F; Orio, F; Palomba, S; Russo, T; Tolino, A; Zullo, F, 2007) |
| "65 kg/m(2)) hirsute women with polycystic ovary syndrome and normal insulin sensitivity were treated with 850 mg metformin orally, three times daily, for 4 months." | 5.12 | Metformin in normal-weight hirsute women with polycystic ovary syndrome with normal insulin sensitivity. ( Baracat, EC; Halpern, A; Maciel, GA; Marcondes, JA; Yamashita, SA, 2007) |
| "Our aim was to assess the effects of metformin on menstrual frequency, fasting plasma glucose (FPG), insulin resistance assessed as HOMA-index, weight, waist/hip ratio, blood pressure (BP), serum lipids, and testosterone levels in women with polycystic ovary syndrome (PCOS) METHODS: In a randomized, controlled, double-blinded setup, 56 women aged 18-45 with PCOS were treated with either metformin 850 mg or placebo twice daily for 6 months." | 5.12 | Efficacy of metformin in obese and non-obese women with polycystic ovary syndrome: a randomized, double-blinded, placebo-controlled cross-over trial. ( Flyvbjerg, A; Kesmodel, U; Lauszus, FF; Trolle, B, 2007) |
| " Objective To prospectively evaluate if administration of metformin to obese, diabetic patients with primary hypothyroidism on stable thyroxine replacement doses modifies TSH levels." | 5.12 | Metformin reduces thyrotropin levels in obese, diabetic women with primary hypothyroidism on thyroxine replacement therapy. ( Cordido, F; Isidro, ML; Nemiña, R; Penín, MA, 2007) |
| "To determine the clinical, hormonal, and biochemical effects of metformin therapy in obese and nonobese patients with polycystic ovary syndrome (PCOS)." | 5.11 | Nonobese women with polycystic ovary syndrome respond better than obese women to treatment with metformin. ( Abi Haidar, M; Alves da Motta, EL; Baracat, EC; de Lima, GR; Maciel, GA; Soares Júnior, JM, 2004) |
| "In a prospective observational study of 42 pregnancies in 39 Caucasian women (age 30 +/- 4 years) with polycystic ovary syndrome (PCOS), we examined effects of metformin on maternal insulin, insulin resistance (IR), insulin secretion (IS), weight gain, development of gestational diabetes (GD), testosterone and plasminogen activator inhibitor activity." | 5.11 | Metformin during pregnancy reduces insulin, insulin resistance, insulin secretion, weight, testosterone and development of gestational diabetes: prospective longitudinal assessment of women with polycystic ovary syndrome from preconception throughout preg ( Glueck, CJ; Goldenberg, N; Loftspring, M; Sherman, A; Wang, P, 2004) |
| "We prospectively assessed growth and motor-social development during the first 18 months of life in 126 live births (122 pregnancies) to 109 women with polycystic ovary syndrome (PCOS) who conceived on and continued metformin (1." | 5.11 | Height, weight, and motor-social development during the first 18 months of life in 126 infants born to 109 mothers with polycystic ovary syndrome who conceived on and continued metformin through pregnancy. ( Glueck, CJ; Goldenberg, N; Loftspring, M; Pranikoff, J; Sieve, L; Wang, P, 2004) |
| "Metformin improves insulin sensitivity, which is correlated to phospholipid fatty acid composition in obese type 2 diabetics." | 5.11 | Effect of metformin vs. placebo treatment on serum fatty acids in non-diabetic obese insulin resistant individuals. ( Christophe, AB; Feyen, E; Giri, M; Rodríguez, Y, 2004) |
| " metformin on the hormonal and biochemical features of patients with polycystic ovarian syndrome (PCOS)." | 5.11 | Orlistat is as beneficial as metformin in the treatment of polycystic ovarian syndrome. ( Atkin, SL; Holding, S; Jayagopal, V; Jennings, PE; Kilpatrick, ES, 2005) |
| " Although long-term treatment with metformin can increase Hcy levels in patients with type II diabetes mellitus or coronary heart disease, it is becoming an increasingly accepted and widespread medication in polycystic ovary syndrome (PCOS)." | 5.11 | Homocysteine levels in women with polycystic ovary syndrome treated with metformin versus rosiglitazone: a randomized study. ( Aslan, E; Bagis, T; Erkanli, S; Haydardedeoglu, B; Kilicdag, EB; Tarim, E; Zeyneloglu, HB, 2005) |
| "The aim of the current study was to assess the effects of B-group vitamins and folic acid administration on serum levels of homocysteine (Hcy) in patients with polycystic ovarian syndrome (PCOS) on short-term metformin treatment." | 5.11 | Administration of B-group vitamins reduces circulating homocysteine in polycystic ovarian syndrome patients treated with metformin: a randomized trial. ( Aslan, E; Bagis, T; Erkanli, S; Haydardedeoglu, B; Kilicdag, EB; Kuscu, E; Simsek, E; Tarim, E, 2005) |
| " The aim of this study was to assess the effects of rosiglitazone and metformin on cardiovascular disease risk factors such as insulin resistance, oxidative stress and homocysteine levels in lean patients with polycystic ovary syndrome (PCOS)." | 5.11 | The effects of rosiglitazone and metformin on oxidative stress and homocysteine levels in lean patients with polycystic ovary syndrome. ( Arslan, M; Ayvaz, G; Bukan, N; Cakir, N; Karakoç, A; Törüner, F; Yilmaz, M, 2005) |
| " There was a significant improvement in hirsutism at the end of the metformin phase compared with placebo: F-G score 15." | 5.10 | The effect of metformin on hirsutism in polycystic ovary syndrome. ( Gordon, D; Kelly, CJ, 2002) |
| " Changes in A1C, fasting plasma glucose, fructosamine, serum lipids, body weight, and 2-h postprandial glucose after a standardized meal were assessed after 16 wk of treatment." | 5.10 | Efficacy of glyburide/metformin tablets compared with initial monotherapy in type 2 diabetes. ( Bruce, S; Dandona, P; Donovan, DS; Garber, AJ; Park, JS, 2003) |
| "The results of this study confirm that sibutramine, orlistat and metformin are all effective and safe medications that reduce cardiovascular risk and can decrease the risk of type 2 diabetes mellitus in obese females." | 5.10 | Evaluation of the safety and efficacy of sibutramine, orlistat and metformin in the treatment of obesity. ( BascilTutuncu, N; Gokcel, A; Gumurdulu, Y; Guvener, N; Karakose, H; Melek Ertorer, E; Tanaci, N, 2002) |
| "The purpose of this study was to assess the effect of orlistat, a gastrointestinal lipase inhibitor, on body weight, glycemic control, and cardiovascular risk factors in metformin-treated type 2 diabetic patients." | 5.10 | Effect of orlistat in overweight and obese patients with type 2 diabetes treated with metformin. ( Anderson, JW; Aronne, L; Doyle, M; Foreyt, J; Hollander, P; Klein, S; Leiter, L; Miles, JM; Wadden, T, 2002) |
| " Body weight, fasting plasma glucose, HbA(1c), blood lactate, total cholesterol and HDL-cholesterol, and triglycerides were measured at the beginning and end of T1 and T5, and end of T2, T3, T6 and T7; postprandial plasma glucose, fasting and postprandial plasma insulin and C-peptide were evaluated at the beginning of T1 and T5, and end of T3 and T7." | 5.09 | A comparison of preconstituted, fixed combinations of low-dose glyburide plus metformin versus high-dose glyburide alone in the treatment of type 2 diabetic patients. ( Coppini, A; Erle, G; Lora, L; Lovise, S; Marchetti, P; Merante, D; Stocchiero, C, 1999) |
| "To assess the effect of metformin on insulin sensitivity, glucose tolerance and components of the metabolic syndrome in patients with impaired glucose tolerance (IGT)." | 5.09 | Metabolic effects of metformin in patients with impaired glucose tolerance. ( Eriksson, JG; Forsén, B; Groop, L; Gullström, M; Häggblom, M; Lehtovirta, M; Taskinen, MR, 2001) |
| "Metformin lowered the LDL/HDL-cholesterol ratio by 12 and 6% at weeks 4 and 12, respectively, and reduced body weight by 1." | 5.08 | Metformin improves blood lipid pattern in nondiabetic patients with coronary heart disease. ( Bjerve, KS; Carlsen, SM; Følling, I; Rossvoll, O, 1996) |
| " Liraglutide is a glucagon-like peptide-1 receptor agonist that promotes sustained weight loss, as well as abdominal fat reduction, in individuals with obesity, prediabetes, and type 2 diabetes mellitus." | 5.05 | Liraglutide: New Perspectives for the Treatment of Polycystic Ovary Syndrome. ( Constantinidou, KG; Filippou, PK; Papaetis, GS; Stylianou, CS, 2020) |
| "The present study firstly provided quantitative information for metformin effects on weight in different disease states, including patients with type 2 diabetes mellitus, patients with antipsychotic induced weight gain, patients with obesity." | 5.05 | Time course and dose effect of metformin on weight in patients with different disease states. ( Chen, X; Li, ZP; Wang, DD, 2020) |
| "08]), but less hypoglycemia as add-on to metformin (odds ratio [OR] 0." | 5.01 | Sodium-Glucose Co-Transporter 2 Inhibitors Compared with Sulfonylureas in Patients with Type 2 Diabetes Inadequately Controlled on Metformin: A Meta-Analysis of Randomized Controlled Trials. ( Chen, Z; Li, G, 2019) |
| "In September 2018, we searched PubMed, Embase, and the Cochrane Library for studies published in English using the keywords metformin, obesity/overweight, and weight loss." | 4.98 | Efficacy of Metformin Treatment with Respect to Weight Reduction in Children and Adults with Obesity: A Systematic Review. ( Knibbe, CAJ; Lentferink, YE; van der Vorst, MMJ, 2018) |
| "English-language trials of benefits or harms of screening or treatment (behavior-based, orlistat, metformin) for overweight or obesity in children aged 2 through 18 years, conducted in or recruited from health care settings." | 4.95 | Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force. ( Burda, BU; Eder, M; Evans, CV; Lozano, P; O'Connor, EA; Walsh, ES, 2017) |
| "We conducted a systematic-review and meta-analysis of metformin versus placebo for change in weight and metabolic syndrome for people on clozapine without diabetes mellitus." | 4.93 | Metformin for Clozapine Associated Obesity: A Systematic Review and Meta-Analysis. ( Kisely, S; Leung, J; Russell, AW; Siskind, DJ; Wysoczanski, D, 2016) |
| "Adding different AHAs to metformin was associated with varying effects on HbA1c, BW, SBP, hypoglycemia, UTI and GTI which should impact clinician choice when selecting adjunctive therapy." | 4.91 | Comparative efficacy and safety of antidiabetic drug regimens added to metformin monotherapy in patients with type 2 diabetes: a network meta-analysis. ( Coleman, CI; Doleh, Y; Kohn, CG; Mearns, ES; Saulsberry, WJ; Sobieraj, DM; White, CM; Zaccaro, E, 2015) |
| "SGLT-2 inhibition in combination with metformin is a potential therapeutic option based on its effects on glycemic control, body weight, and blood pressure, but further trials are required to refine this evidence." | 4.90 | Combinational therapy with metformin and sodium-glucose cotransporter inhibitors in management of type 2 diabetes: systematic review and meta-analyses. ( Dou, J; Lu, J; Zhang, Q, 2014) |
| " These options are mostly new and have the advantage a neutral or favourable (for GLP-1) effect on body weight in obese type 2 DM patient and the absence of any hypoglycaemic risk in both classes of incretins." | 4.89 | [Management of type 2 diabetes: new or previous agents, how to choose?]. ( Halimi, S, 2013) |
| "Sitagliptin is similar to metformin in reducing HbA1c, decreasing body weight, and improving the function of beta cells, but is inferior to metformin in improving insulin sensitivity." | 4.89 | Comparative effects of sitagliptin and metformin in patients with type 2 diabetes mellitus: a meta-analysis. ( Du, Q; Liang, YY; Wang, YJ; Wu, B; Yang, S; Zhao, YY, 2013) |
| " The traditional approach involves: i) metformin, acting mainly on fasting blood glucose; ii) sulphonylureas, that have shown a number of drawbacks, including the high risk of hypoglycemia; iii) pioglitazone, with a substantial effect on fasting and postprandial glucose and a low risk of hypoglycaemia; iv) insulin, that can be utilized with the basal or prandial approach." | 4.89 | What are the preferred strategies for control of glycaemic variability in patients with type 2 diabetes mellitus? ( Marangoni, A; Zenari, L, 2013) |
| " We conclude that metformin may prove useful in macrovascular disease reduction, while pramlintide, glucagon-like peptide-1 agonists, dipeptidyl peptidase-4 inhibitors and leptin co-therapies may reduce HbA(1c) , glucose variability, postprandial glucose excursions and body weight." | 4.89 | Potential role of non-insulin adjunct therapy in Type 1 diabetes. ( George, P; McCrimmon, RJ, 2013) |
| "In patients with type 2 diabetes who do not achieve the glycaemic targets with metformin alone, DPP-4 inhibitors can lower HbA(1c), in a similar way to sulfonylureas or pioglitazone, with neutral effects on body weight." | 4.88 | Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis. ( Karagiannis, T; Matthews, DR; Paletas, K; Paschos, P; Tsapas, A, 2012) |
| "Metformin, an oral anti-diabetic drug, is being considered increasingly for treatment and prevention of cancer, obesity as well as for the extension of healthy lifespan." | 4.88 | Metformin in obesity, cancer and aging: addressing controversies. ( Berstein, LM, 2012) |
| "Substantial evidence confirms the weight benefits of metformin and shows that, of the newer available agents, glucagon-like peptide-1 (GLP-1) agonists and amylin analogs promote weight loss." | 4.87 | Weight beneficial treatments for type 2 diabetes. ( Caputo, S; Damçi, T; Khunti, K; Liebl, A; Meneghini, LF; Orozco-Beltran, D; Ross, SA, 2011) |
| " While metformin has been shown to attenuate weight gain and insulin resistance, not all studies have shown a benefit in the reduction of antipsychotic-induced weight gain and insulin resistance." | 4.86 | The effect of metformin on anthropometrics and insulin resistance in patients receiving atypical antipsychotic agents: a meta-analysis. ( Coleman, CI; Ehret, M; Goethe, J; Lanosa, M, 2010) |
| " Metformin has attracted attention as a potential treatment option because it is thought to result in weight reduction and improved glycemic control in obese patients with and without type 2 diabetes mellitus." | 4.86 | The adjunctive use of metformin to treat or prevent atypical antipsychotic-induced weight gain: a review. ( Ali, F; Dahmen, MM; Girrens, K; Khan, AY; Macaluso, M; McHale, RJ, 2010) |
| " Metformin has been evaluated in clinical studies to prevent or reduce weight gain and changes in metabolic parameters in non-diabetic subjects." | 4.85 | Changes in weight and metabolic parameters during treatment with antipsychotics and metformin: do the data inform as to potential guideline development? A systematic review of clinical studies. ( Bradley, AJ; Bushe, CJ; Doshi, S; Karagianis, J, 2009) |
| "To evaluate the efficacy and safety of metformin for weight management in overweight and obese patients without type 2 diabetes." | 4.84 | Role of metformin for weight management in patients without type 2 diabetes. ( Desilets, AR; Dhakal-Karki, S; Dunican, KC, 2008) |
| "The antidiabetic compound pioglitazone, an activator of the intracellular peroxisome proliferator-activated receptor-gamma, and decreases metabolic and vascular insulin resistance." | 4.83 | Pioglitazone: an antidiabetic drug with cardiovascular therapeutic effects. ( Forst, T; Pfützner, A; Schneider, CA, 2006) |
| "To assess the effectiveness of metformin in improving clinical and biochemical features of polycystic ovary syndrome." | 4.82 | Metformin in polycystic ovary syndrome: systematic review and meta-analysis. ( Flight, IH; Lord, JM; Norman, RJ, 2003) |
| "Metformin has become an established treatment for women with polycystic ovary syndrome, although controversy remains as to how effective it is and in which populations it should be used." | 4.82 | Metformin in polycystic ovary syndrome. ( Lord, J; Wilkin, T, 2004) |
| "The results differ concerning randomized controlled trials of the effects of metformin on blood glucose regulation and body weight." | 4.80 | Efficacy of metformin in the treatment of NIDDM. Meta-analysis. ( Johansen, K, 1999) |
| "Metformin, the most widely prescribed medication for obesity-associated type 2 diabetes (T2D), lowers plasma glucose levels, food intake, and body weight in rodents and humans, but the mechanistic site(s) of action remain elusive." | 4.31 | Metformin triggers a kidney GDF15-dependent area postrema axis to regulate food intake and body weight. ( Barros, DR; Bruce, K; Cherney, DZ; Chiu, JFM; Danaei, Z; Kuah, R; Lam, TKT; Li, RJW; Lim, YM; Mariani, LH; Reich, HN; Zhang, SY, 2023) |
| "We compared the efficacy and safety of beinaglutide, a glucagon-like peptide-1 (GLP-1) analogue with metformin in lowering the bodyweight of patients who were overweight/obese and non-diabetic." | 4.12 | Comparison of Beinaglutide Versus Metformin for Weight Loss in Overweight and Obese Non-diabetic Patients. ( Bi, Y; Feng, W; Fu, Y; Gao, L; Huang, H; Zhang, L; Zhang, N; Zhu, D, 2022) |
| "T2DM patients that performed regular exercise, had normal renal function and were receiving metformin were more likely to have clinically meaningful body weight reduction after one year treatment with dapagliflozin." | 4.12 | Predictors for successful weight reduction during treatment with Dapagliflozin among patients with type 2 diabetes mellitus in primary care. ( Huh, Y; Kim, YS, 2022) |
| "Fifty NMRI mice (7-8 weeks old) were randomly divided into five groups, including non-PCOS, PCOS and PCOS groups treated with clomiphene citrate (18 mg/kg body weight for 2 days), metformin (50 mg/100 g body weight for 30 days) and flutamide (10 mg/kg body weight injection for 15 days)." | 4.12 | Metformin, clomiphene citrate and flutamide effects on oocyte ultrastructure status and quality in PCOS mouse model. ( Esmaeilnezhad, S; Ghasemian, F, 2022) |
| "Linagliptin and its combination with metformin successfully ameliorated diabetic osteoporosis in HFD-fed mice possibly through modulation of BMP-2 and sclerostin." | 4.12 | Linagliptin in Combination With Metformin Ameliorates Diabetic Osteoporosis Through Modulating BMP-2 and Sclerostin in the High-Fat Diet Fed C57BL/6 Mice. ( Nirwan, N; Vohora, D, 2022) |
| " This study intends to examine the effects of sea buckthorn and metformin on body weight, water and feed intake, glycaemia, insulinemia, sorbitol accumulation and cataract development in Zucker diabetic fatty rats, which represent an animal model of type 2 Diabetes mellitus, as well as to characterize the individual content of bioactive substances and the antioxidant activity of sea buckthorn." | 4.12 | The consumption of sea buckthorn (Hippophae rhamnoides L.) effectively alleviates type 2 diabetes symptoms in spontaneous diabetic rats. ( Brindza, J; Capcarova, M; Dupak, R; Hrnkova, J; Ivanisova, E; Kalafova, A; Kovac, J; Prnova, MS; Schneidgenova, M; Simonova, N; Tokarova, K, 2022) |
| " After metformin and exenatide supplementation, body weight, chow intake and ovarian morphology were observed." | 4.02 | Metformin and exenatide upregulate hepatocyte nuclear factor-4α, sex hormone binding globulin levels and improve hepatic triglyceride deposition in polycystic ovary syndrome with insulin resistance rats. ( He, B; Li, X; Lv, B; Wang, D; Xing, C; Zhao, H, 2021) |
| "The present study evaluated the effects of dapagliflozin, a SGLT2 inhibitor, or dapagliflozin plus metformin versus metformin monotherapy in patients with metabolic syndrome." | 4.02 | Dapagliflozin, metformin, monotherapy or both in patients with metabolic syndrome. ( Cheng, L; Fan, Y; Fu, Q; Lin, W; Liu, F; Wu, X; Zhang, X; Zhou, L, 2021) |
| " Metformin is shown to lower body weight and adiposity, but the underlying mechanism is unclear." | 4.02 | Metformin effectively restores the HPA axis function in diet-induced obese rats. ( Balasubramanian, P; Herdt, TH; MohanKumar, PS; MohanKumar, SMJ; Shin, AC; Suryadevara, P; Zyskowski, J, 2021) |
| "Olanzapine treatment increased the body weight, blood glucose and triglyceride levels, and the number of adipocytes in the liver." | 4.02 | Coadministration of metformin prevents olanzapine-induced metabolic dysfunction and regulates the gut-liver axis in rats. ( Huang, HX; Liu, ZQ; Luo, C; Mao, XY; Wang, X; Zhou, HH, 2021) |
| " Metformin has potential effects on improving asthma airway inflammation." | 4.02 | Metformin alleviates allergic airway inflammation and increases Treg cells in obese asthma. ( Chen, M; Guo, Y; Hong, L; Jiang, S; Liu, S; Shi, J; Wang, Q; Yuan, X, 2021) |
| "To explore the effects of second-line combination therapies with metformin on body weight, HbA1c and health-related quality of life, as well as the risks of hypoglycaemia and further treatment intensification in the DISCOVER study, a 3-year, prospective, global observational study of patients with type 2 diabetes initiating second-line glucose-lowering therapy." | 4.02 | Associations between second-line glucose-lowering combination therapies with metformin and HbA1c, body weight, quality of life, hypoglycaemic events and glucose-lowering treatment intensification: The DISCOVER study. ( Charbonnel, B; Chen, H; Cooper, A; Gomes, MB; Ji, L; Khunti, K; Leigh, P; Nicolucci, A; Rathmann, W; Shestakova, MV; Siddiqui, A; Tang, F; Watada, H, 2021) |
| " Because previous data suggest the procognitive potential of the antidiabetic drug metformin, this study aimed to assess the effects of chronic clozapine and metformin oral administration (alone and in combination) on locomotor and exploratory activities and cognitive function in a reward-based test in control and a schizophrenia-like animal model (Wisket rats)." | 4.02 | Interaction of clozapine with metformin in a schizophrenia rat model. ( Adlan, LG; Benyhe, S; Büki, A; Heni, HE; Horvath, G; Kekesi, G; Kis, G; Szűcs, E, 2021) |
| " Berberine, which is a modulator of TRPV1, has proven antiobesity and antidiabetic potentials." | 3.96 | Berberine attenuated olanzapine-induced metabolic alterations in mice: Targeting transient receptor potential vanilloid type 1 and 3 channels. ( Bansal, Y; Bishnoi, M; Kondepudi, KK; Kuhad, A; Medhi, B; Singh, DP; Singh, R; Sodhi, RK, 2020) |
| "The current results suggest that exenatide is equivalent to metformin in controlling insulin resistance, body weight gain, improving liver function, suppressing inflammation, and attenuating NAFLD progression in male rats." | 3.96 | Exenatide ameliorates experimental non-alcoholic fatty liver in rats via suppression of toll-like receptor 4/NFκB signaling: Comparison to metformin. ( Ahmed, AAM; Khodeer, DM; Moustafa, YM; Saad, ZA; Zaitone, SA, 2020) |
| "What is the central question of this study? Studies reported the efficacy of metformin as a promising drug for preventing or treating of metabolic diseases." | 3.96 | Early metformin treatment improves pancreatic function and prevents metabolic dysfunction in early overfeeding male rats at adulthood. ( Alves, VS; de Moraes, AMP; de Oliveira, JC; Francisco, FA; Franco, CCDS; Malta, A; Martins, IP; Mathias, PCF; Matiusso, CCI; Miranda, RA; Moreira, VM; Pavanello, A; Prates, KV; Previate, C, 2020) |
| "Metformin has been reported to decrease insulin resistance and is associated with a lower risk of pregnancy-induced hypertension and preeclampsia." | 3.91 | Effect of Metformin on a Preeclampsia-Like Mouse Model Induced by High-Fat Diet. ( Cao, G; Cao, X; Li, L; Wang, F; Yi, W, 2019) |
| "This study evaluated the preventative effects of metformin (Met) on glucocorticoid (GC)-induced osteoporosis in a rat model, compared with alendronate (Aln)." | 3.91 | Preventative effects of metformin on glucocorticoid-induced osteoporosis in rats. ( Li, Q; Li, Y; Meng, Y; Shi, D; Zhang, H; Zhao, J; Zuo, L, 2019) |
| "In diet-induced obesity, metformin (MF) has weight-lowering effect and improves glucose homeostasis and insulin sensitivity." | 3.91 | The evidence of metabolic-improving effect of metformin in Ay/a mice with genetically-induced melanocortin obesity and the contribution of hypothalamic mechanisms to this effect. ( Bakhtyukov, A; Bayunova, L; Derkach, K; Romanova, I; Shpakov, A; Zakharova, I; Zorina, I, 2019) |
| "Metformin treatment did not affect food intake, body weight, and casual blood glucose levels within each mouse line during the 20-week feeding period." | 3.91 | Metformin Attenuates Early-Stage Atherosclerosis in Mildly Hyperglycemic Oikawa-Nagao Mice. ( Asai, A; Kawahara, M; Miyazawa, T; Nagao, M; Oikawa, S; Shuto, Y; Sugihara, H, 2019) |
| "Metformin decreased glucose concentrations, reduced metabolic syndrome, as well as insulin dose requirement more than insulin therapy alone, 1 year after treatment." | 3.88 | The effects of metformin in type 1 diabetes mellitus. ( Beysel, S; Cakal, E; Caliskan, M; Kizilgul, M; Ucan, B; Unsal, IO, 2018) |
| "Metformin or/and α-LA attenuated the severity of the DSS-induced colitis through improving the reductions in body weights, the DAI, the colonic oxidative stress markers, TNF-α, and NF-κB levels, and the morphological mucosal damage scores." | 3.88 | New insights on the modulatory roles of metformin or alpha-lipoic acid versus their combination in dextran sulfate sodium-induced chronic colitis in rats. ( Elaidy, SM; Essawy, SS; Hassan, MS; Samman, FS, 2018) |
| "These data suggest that metformin protects against bleomycin-induced pulmonary fibrosis through activation of AMPK and amelioration of TGF-β signaling pathways." | 3.88 | Metformin alleviates bleomycin-induced pulmonary fibrosis in rats: Pharmacological effects and molecular mechanisms. ( Arava, S; Arya, DS; Bhatia, J; Gamad, N; Malik, S; Suchal, K; Tomar, A; Vasisht, S, 2018) |
| "The biguanide metformin (MET) has been used during pregnancy for treatment of polycystic ovary syndrome and gestational diabetes." | 3.88 | Intrauterine exposure to metformin: Evaluation of endothelial and perivascular adipose tissue function in abdominal aorta of adult offspring. ( Akamine, EH; Ceravolo, GS; da Silva, MDV; de Andrade, FG; Gerardin, DCC; Montagnini, BG; Moura, KF; Novi, DRBS; Picinin, R; Silva, RNOD; Vidigal, CB, 2018) |
| " Ursolic acid, metformin, gliclazide and their combinations when administered daily for 30 days significantly improved insulin sensitivity apart from behavioral and biochemical alterations in stressed mice." | 3.88 | Synergistic action of ursolic acid and metformin in experimental model of insulin resistance and related behavioral alterations. ( Ahuja, S; Akhtar, A; Kumar, A; Mourya, A; Sah, SP, 2018) |
| "To evaluate the effect of metformin and pioglitazone on leutinizing hormone and follicle stimulating hormone receptor mRNA expression, hyperandrogenism and insulin resistance in high fat diet induced and letrozole induced PCOS in rats." | 3.88 | Insulin Sensitizers Modulate GnRH Receptor Expression in PCOS Rats. ( Patel, R; Shah, G, 2018) |
| "The present study aimed to investigate the effect of metformin on the induction of autophagy in the liver and adipose tissues of a mouse model of obesity." | 3.85 | Metformin ameliorates hepatic steatosis and improves the induction of autophagy in HFD‑induced obese mice. ( Li, M; Sharma, A; Tan, X; Xiao, Y; Yin, C, 2017) |
| " In the present study, we investigated the potential therapeutic effects of metformin (Met) and saxagliptin (Saxa), as insulin sensitizing agents, in a rat model of brain aging and AD using D-galactose (D-gal, 150 mg/kg/day, s." | 3.85 | Involvement of insulin resistance in D-galactose-induced age-related dementia in rats: Protective role of metformin and saxagliptin. ( Attia, A; El-Shenawy, S; Gomaa, N; Hassan, A; Hegazy, R; Kenawy, S; Zaki, H, 2017) |
| " We hypothesized that co-administration of SB extract and metformin exerts a better effect on obesity-induced insulin resistance and lipid metabolism than treatment with metformin alone." | 3.85 | In vivo therapeutic effect of combination treatment with metformin and Scutellaria baicalensis on maintaining bile acid homeostasis. ( Bose, S; Chin, YW; Choi, HS; Han, K; Kim, H; Kim, YM; Lim, SK; Wang, JH, 2017) |
| "We aim to assess the effects of metformin treatment on metabolic and endocrine parameters and genes expression related to the insulin-responsive pathway in polycystic ovary syndrome (PCOS)." | 3.85 | IGF-1R and Leptin Expression Profile and the Effects of Metformin Treatment on Metabolic and Endocrine Parameters in PCOS Mice. ( Abi Haidar, M; Berguio Vidotti, D; de Almeida, BC; de Jesus Simões, M; Prado Correia, LE; Silva, I, 2017) |
| " We evaluated whether obesity exacerbates progression of endometrial hyperplasia (EH) using the PRCre/+ PTENflox/+ mouse model and examined if the type 2 diabetes drug, metformin, could prevent EH." | 3.85 | Lean Body Weight and Metformin Are Insufficient to Prevent Endometrial Hyperplasia in Mice Harboring Inactivating Mutations in PTEN. ( Celestino, J; Iglesias, DA; Lu, KH; Schmandt, RE; Sun, CC; Yates, MS; Zhang, Q, 2017) |
| " In the present study, the effects of metformin on the development and recurrence of hepatocellular carcinoma (HCC) were investigated using the diethylnitrosamine (DEN)‑induced rat model of HCC." | 3.83 | Metformin inhibits early stage diethylnitrosamine‑induced hepatocarcinogenesis in rats. ( Chang, M; Choi, HJ; Jang, JJ; Jang, S; Jo, W; Lee, HJ; Park, HK; Ryu, JE; Son, WC; Yu, ES, 2016) |
| "Metformin reduces body weight by decreasing food intake in humans and animals." | 3.83 | The effect of metformin on neuronal activity in the appetite-regulating brain regions of mice fed a high-fat diet during an anorectic period. ( Choi, SH; Jin, BY; Kim, DH; Kim, HJ; Oh, MJ; Shin, KH, 2016) |
| "Canagliflozin 100 and 300 mg provided sustained reductions in body weight, BMI, and waist circumference in a greater proportion of patients with T2DM versus glimepiride or placebo over 104 weeks." | 3.83 | Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. ( Blonde, L; Canovatchel, W; Fung, A; Meininger, G; Stenlöf, K; Xie, J, 2016) |
| "To investigate changes in body weight trajectories after the addition of individual sulphonylureas (SUs) to metformin in patients with type 2 diabetes." | 3.83 | Addition of sulphonylurea to metformin does not relevantly change body weight: a prospective observational cohort study (ZODIAC-39). ( Bilo, HJ; de Bock, GH; Groenier, KH; Houweling, ST; Kleefstra, N; Landman, GW; Schrijnders, D; van Hateren, KJ; Wever, R, 2016) |
| "We investigated the effects of metformin and celecoxib on obesity-induced adipose tissue inflammation, insulin resistance (IR), fatty liver, and high blood pressure in high-fat (HF) fed rats." | 3.83 | Additional effect of metformin and celecoxib against lipid dysregulation and adipose tissue inflammation in high-fat fed rats with insulin resistance and fatty liver. ( Hsieh, PS; Hung, YJ; Lu, CH, 2016) |
| " This study is to investigate the role of apoA5 in obesity-associated hypertriglyceridemia and metformin-related hypotriglyceridemic actions." | 3.83 | Metformin ameliorates obesity-associated hypertriglyceridemia in mice partly through the apolipoprotein A5 pathway. ( Chen, LZ; Huang, XS; Li, R; Zhao, SP; Zhao, W, 2016) |
| "The methanol (MECR) and aqueous (AECR) extracts (200 and 400mg/kg body weight) were administered orally to normal and diabetic rats with Metformin and solvent control as comparison groups." | 3.83 | Antidiabetic effects of Cuscuta reflexa Roxb. in streptozotocin induced diabetic rats. ( Kar, DM; Maharana, L; Panigrahi, SK; Rath, D, 2016) |
| "The children of mothers with GDM randomised to metformin (n = 47) or insulin (n = 50) treatment during pregnancy." | 3.81 | A follow-up of a randomised study of metformin and insulin in gestational diabetes mellitus: growth and development of the children at the age of 18 months. ( Ijäs, H; Keravuo, R; Raudaskoski, T; Saarela, T; Vääräsmäki, M, 2015) |
| "To determine the effects of metformin therapy in children with metabolic syndrome (MS)." | 3.81 | Metformin treatment improves weight and dyslipidemia in children with metabolic syndrome. ( Ashraf, AP; Luong, DQ; Oster, R, 2015) |
| " We hypothesized that neonatal treatment with antidiabetic drug biguanide metformin would positively modify regulation of growth hormone--IGF-1--insulin signaling pathway slowing down aging and improving cancer preventive patterns in rodents." | 3.81 | Sex differences in aging, life span and spontaneous tumorigenesis in 129/Sv mice neonatally exposed to metformin. ( Anisimov, VN; Egormin, PA; Khaitsev, NV; Panchenko, AV; Popovich, IG; Semenchenko, AV; Trashkov, AP; Tyndyk, ML; Vasiliev, AG; Yurova, MN; Zabezhinski, MA, 2015) |
| "Metformin treatment is associated with a decreased risk and better prognosis of pancreatic cancer (PC) in patients with type 2 diabetes, but the mechanism of metformin's PC growth inhibition in the context of a prediabetic state is unknown." | 3.81 | Metformin and Rapamycin Reduce Pancreatic Cancer Growth in Obese Prediabetic Mice by Distinct MicroRNA-Regulated Mechanisms. ( Cifarelli, V; Devlin, KL; Dunlap, SM; Huang, J; Hursting, SD; Kaaks, R; Lashinger, LM; Pollak, MN, 2015) |
| " Metformin is a first-line treatment of type 2 diabetes, with minimal weight loss in humans." | 3.81 | Synergistic Effects of a GPR119 Agonist with Metformin on Weight Loss in Diet-Induced Obese Mice. ( Al-Barazanji, K; Benson, W; Binz, J; Chen, L; Generaux, C; McNulty, J; Young, A, 2015) |
| "Sixty six adult patients with schizophrenia or schizoaffective disorder treated, with atypical antipsychotics, and who had increased by more than 10% their pre treatment body weight, were randomly assigned to receive metformin or placebo in a double-blind study." | 3.81 | Metformin for treatment of antipsychotic-induced weight gain in a South Asian population with schizophrenia or schizoaffective disorder: A double blind, randomized, placebo controlled study. ( Dayabandara, M; de Silva, VA; Gunewardena, H; Hanwella, R; Henegama, T; Suraweera, C; Wijesundara, H, 2015) |
| "Metformin decreases polycystic ovary syndrome (PCOS) symptoms, induces ovulation, and may improve developmental competence of in vitro oocyte maturation." | 3.81 | Does metformin improve in vitro maturation and ultrastructure of oocytes retrieved from estradiol valerate polycystic ovary syndrome-induced rats. ( Mesbah, F; Mirkhani, H; Moslem, M; Vojdani, Z, 2015) |
| "The aim of our study was to assess the value of blood pressure and heart rate using the 24-hour blood pressure monitoring (ABPM) before and after treatment with metformin to patients with polycystic ovary syndrome (PCOS) and normal lean." | 3.81 | [Metformin and changes in blood pressure and heart rate in lean patients with polycystic ovary syndrome (PCOS)--preliminary study]. ( Kiałka, M; Klocek, M; Kowalczuk, A; Migacz, K; Milewicz, T; Ociepka, A; Tomczyk, R, 2015) |
| "In the present study, the ability of metformin to inhibit skin tumor promotion by 12-O-tetradecanoylphorbol-13-acetate (TPA) was analyzed in mice maintained on either an overweight control diet or an obesity-inducing diet." | 3.80 | Metformin inhibits skin tumor promotion in overweight and obese mice. ( Angel, JM; Beltran, L; Blando, J; Checkley, LA; Cho, J; DiGiovanni, J; Hursting, SD; Rho, O, 2014) |
| "Over a 20-year period, patients on dapagliflozin were projected to experience relative reductions in the incidence of myocardial infarction (MI), stroke, CV death, and all-cause death of 13." | 3.80 | Modeling effects of SGLT-2 inhibitor dapagliflozin treatment versus standard diabetes therapy on cardiovascular and microvascular outcomes. ( Alperin, P; Cohen, M; Dziuba, J; Goswami, D; Grossman, HL; Hardy, E; Iloeje, U; Perlstein, I; Racketa, J, 2014) |
| "Danish individuals without prior myocardial infarction or stroke that initiated combinations of metformin with sulphonylurea (SU), DPP-4 inhibitors, GLP-1 agonists or insulin between 9 May 2007 and 31 December 2011 were followed up for the risk of all-cause mortality, cardiovascular (CV) mortality or a combined end point of myocardial infarction, stroke and CV mortality." | 3.80 | Cardiovascular safety of combination therapies with incretin-based drugs and metformin compared with a combination of metformin and sulphonylurea in type 2 diabetes mellitus--a retrospective nationwide study. ( Andersson, C; Fosbøl, EL; Gislason, G; Køber, L; Mogensen, UM; Scheller, NM; Schramm, TK; Torp-Pedersen, C; Vaag, A, 2014) |
| "Metformin could retard body weight gain, improve insulin sensitivity and reduce intramyocellular lipid accumulation in ob/ob mice." | 3.80 | Metformin suppresses lipid accumulation in skeletal muscle by promoting fatty acid oxidation. ( Hu, P; Li, Q; Li, Z; Liu, F; Wang, C; Wang, H; Wu, J; Ye, J; Yuan, Y; Zhang, L, 2014) |
| "Metformin is commonly used as the first line of medication for the treatment of metabolic syndromes, such as obesity and type 2 diabetes (T2D)." | 3.80 | Effect of metformin on metabolic improvement and gut microbiota. ( Ko, G; Lee, H, 2014) |
| "Elevated asymmetric dimethylarginine (ADMA) levels and nitric oxide (NO) deficiency are associated with the development of hypertension." | 3.80 | Metformin reduces asymmetric dimethylarginine and prevents hypertension in spontaneously hypertensive rats. ( Hsu, CN; Huang, LT; Kuo, HC; Tain, YL; Tsai, CM, 2014) |
| "Metformin administration resulted in significant decrease in the body weight, body mass index, hirsutism score, fasting and postprandial blood glucose, fasting serum insulin, HOMA index, sleep disturbances scale, and Epworth sleepiness scale compared to the untreated PCOS group." | 3.80 | Effect of metformin on sleep disorders in adolescent girls with polycystic ovarian syndrome. ( Abdelmotaleb, GS; Aly, MK; El-Sharkawy, AA; Kabel, AM, 2014) |
| "The antidiabetic drug metformin is currently used prior and during pregnancy for polycystic ovary syndrome, as well as during gestational diabetes mellitus." | 3.79 | Prenatal metformin exposure in mice programs the metabolic phenotype of the offspring during a high fat diet at adulthood. ( Ailanen, L; Ilyasizadeh, J; Jäppinen, NT; Koulu, M; Laurila, K; Penttinen, AM; Pesonen, U; Salomäki, H; Vähätalo, LH, 2013) |
| "Obesity is becoming a health concern worldwide and metformin, a first line anti-diabetic drug, was associated with weight loss under different backgrounds." | 3.79 | Effect of metformin on the urinary metabolites of diet-induced-obese mice studied by ultra performance liquid chromatography coupled to time-of-flight mass spectrometry (UPLC-TOF/MS). ( Cong, W; Feng, Y; Ruan, K; Shen, L; Wang, B; Xu, D; Zhu, Y, 2013) |
| "Telmisartan acts beneficially against diabetes-induced inflammation and improves insulin resistance in pre-diabetes OLETF rats fed with HFD." | 3.79 | Angiotensin II receptor blocker telmisartan prevents new-onset diabetes in pre-diabetes OLETF rats on a high-fat diet: evidence of anti-diabetes action. ( Li, LY; Luo, R; Sun, LT; Tian, FS; Xiong, HL; Zhao, ZQ; Zheng, XL, 2013) |
| " As a result of the proposed method of treatment had improved the clinical course of CCH due to lower body weight, body mass index (BMI) and abdominal obesity indexes (AOI), which were characterized by decreasing the duration and frequency of angina attacks, reducing the number of nitroglycerin tablets taken, and also increased exercise tolerance (ET)." | 3.79 | [Оptimization of stable angina standard therapy in patients with concomitant osteoarthritis and obesity]. ( Teslenko, IuV, 2013) |
| "Gemfibrozil is a PPAR-α ligand that inhibits the progression of atherosclerosis in insulin resistance type 2 diabetes mellitus (IR type 2 DM)." | 3.79 | Gemfibrozil and its combination with metformin on pleiotropic effect on IL-10 and adiponectin and anti-atherogenic treatment in insulin resistant type 2 diabetes mellitus rats. ( Kurmi, MK; Raikwar, SK; Sharma, AK; Srinivasan, BP, 2013) |
| "Metformin is widely used to treat obese diabetics because of its beneficial effects on body weight, energy intake, and glucose regulation." | 3.79 | Metformin decreases meal size and number and increases c-Fos expression in the nucleus tractus solitarius of obese mice. ( Choi, SH; Chun, BG; Kim, DH; Kim, HJ; Park, EY; Shin, KH; Zhang, XH, 2013) |
| "The pharmacokinetics of metformin was influenced by lean body weight on an allometric basis and was related to markers of renal function, age, and serum creatinine in this population of 105 patients." | 3.78 | Population pharmacokinetics of metformin in obese and non-obese patients with type 2 diabetes mellitus. ( Bardin, C; Chast, F; Larger, E; Nobecourt, E; Treluyer, JM; Urien, S, 2012) |
| " Furthermore, the body weight, liver glycogen formation, antioxidant substance (GSH) and antioxidant enzyme (SOD and GPX) levels increased evidently in diabetic mice treated with both ASP and metformin." | 3.78 | Anti-diabetic activities of Acanthopanax senticosus polysaccharide (ASP) in combination with metformin. ( Fu, G; Fu, J; Gao, B; Tu, Y; Yuan, J; Zhang, N; Zhang, Y, 2012) |
| "After 6 weeks treatment, metformin reduced the body weight gain and enhanced insulin sensitivity of high-fat fed rats." | 3.78 | Downregulation of chemerin and alleviation of endoplasmic reticulum stress by metformin in adipose tissue of rats. ( Ao, N; Du, J; Liu, H; Pei, L; Yang, J; Zhang, Y, 2012) |
| " At the end of the feeding schedule, Dia group had insulin resistance along with increased blood glucose, triglyceride, uric acid and nitric oxide (NO) levels." | 3.78 | Attenuation of insulin resistance, metabolic syndrome and hepatic oxidative stress by resveratrol in fructose-fed rats. ( Bagul, PK; Banerjee, SK; Bastia, T; Chakravarty, S; Madhusudana, K; Matapally, S; Middela, H; Padiya, R; Reddy, BR, 2012) |
| " We hypothesised that intervention with metformin would diminish the HF-feeding-evoked cognitive deficit by improving insulin sensitivity." | 3.78 | A high-fat-diet-induced cognitive deficit in rats that is not prevented by improving insulin sensitivity with metformin. ( Balfour, DJ; McNeilly, AD; Stewart, CA; Sutherland, C; Williamson, R, 2012) |
| "To define the pharmacogenetic features of the effect of metformin in coronary heart disease (CHD) patients with metabolic syndrome (MS) or type 2 diabetes mellitus (T2DM), by taking into consideration PPAR-gamma2 Pro1 2Ala polymorphism." | 3.78 | [Pharmacogenetic features of the effect of metformin in patients with coronary heart disease in the presence of metabolic syndrome and type 2 diabetes mellitus in terms of PPAR-gamma2 gene polymorphism]. ( Kaĭdashev, IP; Kutsenko, LA; Lavrenko, AV; Mamontova, TV; Shlykova, OA, 2012) |
| " Metformin treatment improved the insulin sensitivity, and normalized the in vitro bladder hypercontractility and cystometric dysfunction in obese mice." | 3.78 | Role of PKC and CaV1.2 in detrusor overactivity in a model of obesity associated with insulin resistance in mice. ( Anhê, GF; Antunes, E; Calixto, MC; De Nucci, G; Grant, AD; Leiria, LO; Lintomen, L; Mónica, FZ; Sollon, C; Zanesco, A, 2012) |
| " We studied the metabolic effects of treatment with mildronate, metformin and a combination of the two in the Zucker rat model of obesity and impaired glucose tolerance." | 3.77 | Anti-diabetic effects of mildronate alone or in combination with metformin in obese Zucker rats. ( Cirule, H; Dambrova, M; Liepinsh, E; Makrecka, M; Skapare, E; Svalbe, B, 2011) |
| " The chronic treatment of inbred 129/Sv mice with metformin (100 mg/kg in drinking water) slightly modified the food consumption but failed to influence the dynamics of body weight, decreased by 13." | 3.76 | Gender differences in metformin effect on aging, life span and spontaneous tumorigenesis in 129/Sv mice. ( Anisimov, VN; Berstein, LM; Egormin, PA; Kovalenko, IG; Piskunova, TS; Popovich, IG; Poroshina, TE; Rosenfeld, SV; Semenchenko, AV; Tyndyk, ML; Yurova, MV; Zabezhinski, MA, 2010) |
| " We followed the spontaneous evolution of liver steatosis and tested the therapeutic usefulness of metformin and fenofibrate in a model of steatosis, the Zucker diabetic fatty (ZDF) rat." | 3.75 | Nonalcoholic hepatic steatosis in Zucker diabetic rats: spontaneous evolution and effects of metformin and fenofibrate. ( Abdallah, P; Basset, A; Beylot, M; del Carmine, P; Forcheron, F; Haffar, G, 2009) |
| "Women with GDM treated with metformin and with similar baseline risk factors for adverse pregnancy outcomes had less weight gain and improved neonatal outcomes compared with those treated with insulin." | 3.75 | Pregnancy outcomes in women with gestational diabetes treated with metformin or insulin: a case-control study. ( Balani, J; Hyer, SL; Rodin, DA; Shehata, H, 2009) |
| " These mice also have enhanced inflammatory responses to ozone, a common air pollutant that exacerbates asthma." | 3.74 | No effect of metformin on the innate airway hyperresponsiveness and increased responses to ozone observed in obese mice. ( Shore, SA; Williams, ES; Zhu, M, 2008) |
| " Here we show the chronic treatment of female outbred SHR mice with metformin (100 mg/kg in drinking water) slightly modified the food consumption but decreased the body weight after the age of 20 months, slowed down the age-related switch-off of estrous function, increased mean life span by 37." | 3.74 | Metformin slows down aging and extends life span of female SHR mice. ( Anisimov, VN; Berstein, LM; Egormin, PA; Kovalenko, IG; Piskunova, TS; Popovich, IG; Poroshina, TE; Semenchenko, AV; Tyndyk, ML; Yurova, MV; Zabezhinski, MA, 2008) |
| "The objective of this study was to quantify 1-year weight gain associated with the initiation of sulphonylurea (SU), metformin, insulin and thiazolidinedione (TZD) therapy in a representative real world population of type 2 diabetic patients." | 3.74 | Weight changes following the initiation of new anti-hyperglycaemic therapies. ( Gomez-Caminero, A; Nichols, GA, 2007) |
| "The effect of 6 months of metformin treatment was prospectively assessed in 188 PCOS patients, divided into three groups according to body mass index (BMI; lean: BMI<25 kg/m2, overweight: BMI 25-29 kg/m2, and obese: BMI30 kg/m2)." | 3.74 | Metformin improves polycystic ovary syndrome symptoms irrespective of pre-treatment insulin resistance. ( Benson, S; Dietz, T; Elsenbruch, S; Hahn, S; Janssen, OE; Kimmig, R; Lahner, H; Mann, K; Moeller, LC; Schmidt, M; Tan, S, 2007) |
| "The aim of the present study was to evaluate the effect of metformin in very obese subjects with acanthosis nigricans." | 3.71 | Therapeutic approach in insulin resistance with acanthosis nigricans. ( Dakovska, L; Kirilov, G; Koev, D; Tankova, T, 2002) |
| "After adding metformin to the insulin regimen of type 2 diabetics after three months a statistically significant drop of body weight and the daily insulin dose occurred." | 3.71 | [Short-term and long-term effect of metformin in type 1 diabetics]. ( Cechurová, D; Jankovec, Z; Kárová, R; Kyselová, P; Lacigová, S; Rusavý, Z, 2001) |
| "55 g/d for 28 weeks) would ameliorate morbid obesity and reduce centripetal obesity; lipid and lipoprotein cholesterol, insulin, and leptin levels; and plasminogen activator inhibitor activity (PAI-Fx), risk factors for coronary heart disease (CHD)." | 3.71 | Metformin reduces weight, centripetal obesity, insulin, leptin, and low-density lipoprotein cholesterol in nondiabetic, morbidly obese subjects with body mass index greater than 30. ( Fontaine, RN; Glueck, CJ; Illig, E; Lang, JE; McCullough, P; Sieve-Smith, L; Streicher, P; Subbiah, MT; Tracy, TM; Wang, P; Weber, K, 2001) |
| "To evaluate the long-term effects of metformin on biochemical variables and body weight in polycystic ovary syndrome (PCOS)." | 3.71 | Biochemical and body weight changes with metformin in polycystic ovary syndrome. ( Batukan, C; Batukan, M; Baysal, B, 2001) |
| "Before metformin therapy, after covariance adjustment for age, the two cohorts did not differ in height, weight, basal metabolic index, insulin, insulin resistance, or insulin secretion." | 3.71 | Metformin therapy throughout pregnancy reduces the development of gestational diabetes in women with polycystic ovary syndrome. ( Glueck, CJ; Kobayashi, S; Phillips, H; Sieve-Smith, L; Wang, P, 2002) |
| "HCl and metformin on diabetes and obesity were investigated in Wistar fatty rats, which are hyperglycaemic and hypertriglyceridaemic and have higher plasma levels of total ketone bodies than lean rats." | 3.71 | Effects of combined pioglitazone and metformin on diabetes and obesity in Wistar fatty rats. ( Ikeda, H; Odaka, H; Sugiyama, Y; Suzuki, M; Suzuki, N, 2002) |
| " The aim was to define the insulin-sensitizing effects of S15261, the cleavage products, and troglitazone and metformin in the JCR:LA-cp rat, an animal model of the obesity/insulin resistance syndrome that exhibits an associated vasculopathy and cardiovascular disease." | 3.70 | Beneficial insulin-sensitizing and vascular effects of S15261 in the insulin-resistant JCR:LA-cp rat. ( Brindley, DN; Davidge, ST; Delrat, P; Jochemsen, R; Kelly, SE; O'Brien, SF; Pégorier, JP; Ravel, D; Russell, JC, 2000) |
| "The hypothalamic neuropeptide Y content and preproneuropeptide Y mRNA expression were studied in metformin-treated (300 mg/kg orally for 12 days), in pair-fed and in ad libitum-fed obese Zucker rats in order to elucidate possible mechanisms involved in the anorectic and body weight reducing effect of chronic metformin treatment in genetically obese Zucker rats." | 3.69 | Anorectic effect of metformin in obese Zucker rats: lack of evidence for the involvement of neuropeptide Y. ( Huupponen, R; Jhanwar-Uniyal, M; Koulu, M; Pesonen, U; Rouru, J; Rouvari, T; Santti, E; Virtanen, K, 1995) |
| "To determine the relationship between hyperinsulinemia and hypertension in spontaneously hypertensive rats (SHR), the antihyperglycemic agent metformin was administered to SHR and their Wistar-Kyoto (WKY) controls, and its effects on plasma insulin levels and blood pressure were examined." | 3.69 | Metformin decreases plasma insulin levels and systolic blood pressure in spontaneously hypertensive rats. ( Bhanot, S; McNeill, JH; Verma, S, 1994) |
| "To determine whether improvement of insulin resistance decreases blood pressure as well as obesity, metformin (100 mg/kg/d) or vehicle was administered for 20 weeks to 12-week-old male Otsuka Long-Evans Tokushima Fatty (OLETF) rats (n = 10 each), a newly developed animal model of non-insulin-dependent diabetes mellitus (NIDDM) with mild obesity, hyperinsulinemia, and hypertriglyceridemia." | 3.69 | Metformin decreases blood pressure and obesity in OLETF rats via improvement of insulin resistance. ( Inukai, K; Ishii, J; Kashiwabara, H; Katayama, S; Kikuchi, C; Kosegawa, I; Negishi, K; Oka, Y, 1996) |
| "A retrospective analysis was conducted to determine the effects of metformin on glycosylated hemoglobin (HbA1c), body weight, and adverse events in an African-American population." | 3.69 | A retrospective analysis of the efficacy and safety of metformin in the African-American patient. ( Anderson, D; Briscoe, TA; Cooper, GS; Usifo, OS, 1997) |
| "The effect of metformin on glucose metabolism was examined in eight obese (percent ideal body weight, 151 +/- 9%) and six lean (percent ideal body weight, 104 +/- 4%) noninsulin-dependent diabetic (NIDD) subjects before and after 3 months of metformin treatment (2." | 3.68 | Mechanism of metformin action in obese and lean noninsulin-dependent diabetic subjects. ( Barzilai, N; DeFronzo, RA; Simonson, DC, 1991) |
| "In people with type 2 diabetes on metformin, 26-week treatment with iGlarLixi resulted in a marked improvement in β-cell function concomitant with sparing of endogenous insulin release and a reduction in meal absorption." | 3.11 | Fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) improves ß-cell function in people with type 2 diabetes. ( Dex, T; Ferrannini, E; Mari, A; Niemoeller, E; Servera, S, 2022) |
| " Consistent with the GLP-1 RA class, gastrointestinal adverse events were most commonly reported; these were generally transient and mild/moderate in severity." | 3.11 | Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial. ( Baek, S; Choi, J; Frias, JP; Muehlen-Bartmer, I; Niemoeller, E; Popescu, L; Rosenstock, J, 2022) |
| " There was no significant difference in the rate of adverse events for tirzepatide 15 mg, oral-semaglutide 14 mg, and semaglutide 1." | 3.01 | Comparison of the efficacy and safety of 10 glucagon-like peptide-1 receptor agonists as add-on to metformin in patients with type 2 diabetes: a systematic review. ( Chen, J; Gu, H; Hu, J; Li, M; Xie, Z, 2023) |
| "Type 2 diabetes mellitus is closely related to nonalcoholic fatty liver disease(NAFLD)." | 2.94 | Liraglutide or insulin glargine treatments improves hepatic fat in obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks: A randomized placebo-controlled trial. ( Guo, W; Lin, L; Tian, W; Xu, X, 2020) |
| "Metformin led to an increase in AMPK signaling, and a trend for blunted increases in mTORC1 signaling in response to PRT." | 2.90 | Metformin blunts muscle hypertrophy in response to progressive resistance exercise training in older adults: A randomized, double-blind, placebo-controlled, multicenter trial: The MASTERS trial. ( Bamman, MM; Bush, HM; Dungan, CM; Kern, PA; Kosmac, K; Long, DE; McGwin, G; Ovalle, F; Peck, BD; Peterson, CA; Tuggle, SC; Villasante Tezanos, AG; Walton, RG; Windham, ST, 2019) |
| "More dapagliflozintreated than saxagliptin-treated patients achieved the composite endpoint of HbA1c reduction ≥ 0." | 2.87 | Dapagliflozin versus saxagliptin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin. ( Chen, H; Garcia-Sanchez, R; Mathieu, C; Rosenstock, J; Saraiva, GL, 2018) |
| "Prediabetes is associated with increased prevalence of cardiovascular disease (CVD)." | 2.87 | Effect of intensive lifestyle modification & metformin on cardiovascular risk in prediabetes: A pilot randomized control trial. ( Bantwal, G; Fathima, S; George, B; Kulkarni, S; Umesh, S; Xavier, D, 2018) |
| "The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial documented that metformin plus rosiglitazone, but not metformin plus lifestyle intervention, provided superior durability of glycemic control relative to metformin monotherapy." | 2.84 | Weight change in the management of youth-onset type 2 diabetes: the TODAY clinical trial experience. ( El Ghormli, L; Hirst, K; Ievers-Landis, CE; Linder, B; Marcus, MD; van Buren, DJ; Walders-Abramson, N; Wilfley, DE; Zeitler, P, 2017) |
| "Metformin-treated patients with T2DM also have higher fasted GLP-1 levels, independently of weight and glycaemia." | 2.84 | Sustained influence of metformin therapy on circulating glucagon-like peptide-1 levels in individuals with and without type 2 diabetes. ( Dawed, A; Dekker, J; Franks, PW; Hansen, TH; Heggie, A; Holman, RR; Jones, AG; Koivula, R; Pearson, ER; Preiss, D; Sattar, N; Stewart, C; Walker, M; Welsh, P, 2017) |
| "To assess the effect of metformin versus placebo both in combination with insulin analogue treatment on changes in carotid intima-media thickness (IMT) in patients with type 2 diabetes." | 2.82 | Metformin versus placebo in combination with insulin analogues in patients with type 2 diabetes mellitus-the randomised, blinded Copenhagen Insulin and Metformin Therapy (CIMT) trial. ( Almdal, TP; Boesgaard, TW; Breum, L; Carstensen, B; Duun, E; Gade-Rasmussen, B; Gluud, C; Hedetoft, C; Hemmingsen, B; Jensen, T; Krarup, T; Lund, SS; Lundby-Christensen, L; Madsbad, S; Mathiesen, ER; Pedersen, O; Perrild, H; Røder, M; Sneppen, SB; Snorgaard, O; Tarnow, L; Thorsteinsson, B; Vaag, A; Vestergaard, H; Wetterslev, J; Wiinberg, N, 2016) |
| "Participants with type 2 diabetes (glycated haemoglobin (HbA1c) ≥ 7." | 2.82 | Effects of biphasic, basal-bolus or basal insulin analogue treatments on carotid intima-media thickness in patients with type 2 diabetes mellitus: the randomised Copenhagen Insulin and Metformin Therapy (CIMT) trial. ( Almdal, TP; Boesgaard, TW; Breum, L; Carstensen, B; Duun, E; Gade-Rasmussen, B; Gluud, C; Hedetoft, C; Hemmingsen, B; Jensen, T; Krarup, T; Lund, SS; Lundby-Christensen, L; Madsbad, S; Mathiesen, ER; Pedersen, O; Perrild, H; Røder, M; Sneppen, SB; Snorgaard, O; Tarnow, L; Thorsteinsson, B; Vaag, A; Vestergaard, H; Wetterslev, J; Wiinberg, N, 2016) |
| " The mean terminal half-life (t1/2 ) was 2-3 h." | 2.82 | Safety, tolerability, pharmacokinetics and pharmacodynamics of AZP-531, a first-in-class analogue of unacylated ghrelin, in healthy and overweight/obese subjects and subjects with type 2 diabetes. ( Abribat, T; Allas, S; Delale, T; Julien, M; Ngo, N; Ritter, J; Sahakian, P; van der Lely, AJ, 2016) |
| "After run-in on metformin and basal-bolus insulin (BBI), 102 participants continued metformin and basal insulin and were randomized to exenatide dosing before the two largest meals (glucacon-like peptide-1 receptor agonist and insulin [GLIPULIN group]) or continuation of rapid-acting insulin analogs (BBI group)." | 2.82 | Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk. ( , 2016) |
| "LixiLan achieved statistically significant reductions to near-normal HbA1c levels with weight loss and no increased hypoglycemic risk, compared with insulin glargine alone, and a low incidence of gastrointestinal adverse events in type 2 diabetes inadequately controlled on metformin." | 2.82 | Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Lixisenatide and Insulin Glargine, Versus Insulin Glargine in Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy: The LixiLan Proof-of-Concept Randomized Trial. ( Aroda, VR; Diamant, M; Fonseca, V; Perfetti, R; Rosenstock, J; Silvestre, L; Souhami, E; Zhou, T, 2016) |
| "This multicenter, double-blind, placebo-controlled study examined the efficacy and safety of ipragliflozin, a sodium-glucose co-transporter 2 inhibitor, in combination with metformin in Japanese patients with type 2 diabetes mellitus (T2DM)." | 2.80 | Ipragliflozin in combination with metformin for the treatment of Japanese patients with type 2 diabetes: ILLUMINATE, a randomized, double-blind, placebo-controlled study. ( Goto, K; Kashiwagi, A; Kazuta, K; Ueyama, E; Utsuno, A; Yoshida, S, 2015) |
| "To evaluate the efficacy and safety of twice-daily dosing of dapagliflozin and metformin, exploring the feasibility of a fixed-dose combination." | 2.80 | Twice-daily dapagliflozin co-administered with metformin in type 2 diabetes: a 16-week randomized, placebo-controlled clinical trial. ( Burgess, L; de Bruin, TW; Hamer-Maansson, JE; Hruba, V; Korányi, L; Schumm-Draeger, PM, 2015) |
| " Changes in HbA1c level, fasting plasma glucose and body weight, as well as adverse events, were assessed over 102 weeks." | 2.80 | Efficacy and safety of dapagliflozin monotherapy in people with Type 2 diabetes: a randomized double-blind placebo-controlled 102-week trial. ( Bailey, CJ; List, JF; Morales Villegas, EC; Ptaszynska, A; Tang, W; Woo, V, 2015) |
| "People with insulin-requiring type 2 diabetes and high cardiovascular risk were enrolled during a run-in period on basal-bolus insulin (BBI), and 102 were randomized to continued BBI or to basal insulin with a prandial GLP-1 receptor agonist (GLIPULIN) group, each seeking to maintain HbA(1c) levels between 6." | 2.80 | Design of FLAT-SUGAR: Randomized Trial of Prandial Insulin Versus Prandial GLP-1 Receptor Agonist Together With Basal Insulin and Metformin for High-Risk Type 2 Diabetes. ( Bergenstal, R; Branch, KR; Davis, B; Hirsch, I; Khakpour, D; Kingry, C; O'Brien, K; Pressel, S; Probstfield, JL; Riddle, M, 2015) |
| "Metformin plays an important role in diabetes treatment." | 2.80 | The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial. ( Chen, X; Guo, J; Li, Z; Lian, F; Ma, L; Piao, C; Tian, J; Tong, X; Wang, CZ; Xia, C; Yuan, CS; Zhao, L, 2015) |
| "Metformin treatment had no substantial influence on tofogliflozin efficacy." | 2.80 | A novel and selective sodium-glucose cotransporter-2 inhibitor, tofogliflozin, improves glycaemic control and lowers body weight in patients with type 2 diabetes mellitus. ( Beck, A; Beyer, U; Boerlin, V; Christ, AD; Ciorciaro, C; Cynshi, O; Ikeda, S; Kadowaki, T; Meyer, M; Takano, Y; Tanaka, R, 2015) |
| "Patients with type 2 diabetes mellitus (T2DM) using sulphonylurea and metformin received dapagliflozin 10 mg/day or placebo added to therapy for 52 weeks (24-week randomized, double-blind period plus 28-week double-blind extension)." | 2.80 | Durability and tolerability of dapagliflozin over 52 weeks as add-on to metformin and sulphonylurea in type 2 diabetes. ( Bowering, K; Johnsson, E; Matthaei, S; Parikh, S; Rohwedder, K; Sugg, J, 2015) |
| "Among overweight adolescents with type 1 diabetes, the addition of metformin to insulin did not improve glycemic control after 6 months." | 2.80 | Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial. ( Beck, RW; Bethin, KE; Coffey, JK; DiMeglio, LA; Haller, MJ; Katz, ML; Libman, IM; Miller, KM; Nadeau, KJ; Raman, S; Saenz, AM; Shah, A; Simmons, JH; Tamborlane, WV, 2015) |
| " Safety and tolerability assessments included adverse events (AEs), hypoglycaemia and body weight." | 2.79 | A randomized controlled trial of the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes and inadequate glycaemic control on metformin plus a sulphonylurea. ( Brook, D; Fisher, SA; Kalra, S; Montanaro, M; Monyak, J; Moses, RG; Sockler, J; Visvanathan, J, 2014) |
| "0 pmol/kg/min (pkm) and placebo, given by continuous subcutaneous infusion over 3 months in combination with metformin and sulphonylurea (SU), to lower haemoglobin A1c (HbA1c), fasting plasma glucose and weight in 95 type 2 diabetes patients with inadequate glycaemic control." | 2.79 | Dose response of continuous subcutaneous infusion of recombinant glucagon-like peptide-1 in combination with metformin and sulphonylurea over 12 weeks in patients with type 2 diabetes mellitus. ( Ehlers, MR; Holst, JJ; Torekov, SS, 2014) |
| "Dapagliflozin treatment induced glucosuria and markedly lowered fasting plasma glucose." | 2.79 | Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production. ( Abdul-Ghani, MA; Daniele, G; DeFronzo, RA; Eldor, R; Fiorentino, TV; Merovci, A; Norton, L; Perez, Z; Solis-Herrera, C; Tripathy, D; Xiong, J, 2014) |
| " Glycosylated hemoglobin (HbA1c) values, fasting and postprandial blood glucose (FBG and P2BG), body weight, body mass index (BMI), episodes of hypoglycemia and adverse events were evaluated." | 2.79 | Efficacy and safety comparison of add-on therapy with liraglutide, saxagliptin and vildagliptin, all in combination with current conventional oral hypoglycemic agents therapy in poorly controlled Chinese type 2 diabetes. ( Ding, M; Li, CJ; Liu, XJ; Yu, DM; Yu, P; Yu, Q; Zhang, QM, 2014) |
| " Over 52 weeks, nausea, diarrhea, and vomiting were the most common adverse events; incidences were similar between dulaglutide and metformin." | 2.79 | Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). ( Pechtner, V; Pérez Manghi, F; Shurzinske, L; Tofé Povedano, S; Umpierrez, G, 2014) |
| " Rates of serious adverse events in the albiglutide group were similar to comparison groups." | 2.79 | HARMONY 3: 104-week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin. ( Ahrén, B; Cirkel, DT; Feinglos, MN; Johnson, SL; Perry, C; Stewart, M; Yang, F, 2014) |
| " Pharmacodynamic parameters were assessed at baseline and at weeks 1 and 12." | 2.79 | Effect of the sodium glucose co-transporter 2 inhibitor canagliflozin on plasma volume in patients with type 2 diabetes mellitus. ( Farrell, K; Heise, T; Natarajan, J; Plum-Mörschel, L; Polidori, D; Rothenberg, P; Sha, S; Sica, D; Wang, SS, 2014) |
| " Adverse events (AE) and hypoglycemia were monitored." | 2.79 | Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. ( Bryzinski, B; Cook, W; Hirshberg, B; Minervini, G, 2014) |
| "We recruited 25 patients with type 1 diabetes (mean age 51 ± 10 years, mean disease duration 26 ± 13 years) and 31 insulin-treated type 2 diabetic patients (mean age 66 ± 8 years, mean disease duration 19 ± 9 years), who received sitagliptin with metformin as a fixed-dose combination (50/1000 mg once or twice daily) or sitagliptin (100 mg once daily, if intolerant to metformin) in addition to ongoing insulin therapy for 46 ± 19 weeks and 56 ± 14 weeks, respectively." | 2.78 | Sitagliptin as add-on therapy in insulin deficiency: biomarkers of therapeutic efficacy respond differently in type 1 and type 2 diabetes. ( Bartola, LD; Giampietro, C; Giampietro, O; Masoni, MC; Matteucci, E, 2013) |
| "These data suggest that normal-weight type 2 diabetes patients would derive the same benefits from first-line treatment with metformin as overweight and obese patients, and are not at increased risk of excess weight loss." | 2.78 | Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients: phase IV open-label trial. ( Guo, X; Hu, R; Ji, L; Li, H; Li, Y; Zhu, Z, 2013) |
| "Pioglitazone was more effective than glibenclamide in improving inflammation and hepatic steatosis indices." | 2.78 | Ultrasonography modifications of visceral and subcutaneous adipose tissue after pioglitazone or glibenclamide therapy combined with rosuvastatin in type 2 diabetic patients not well controlled by metformin. ( D'Angelo, A; Derosa, G; Fogari, E; Maffioli, P; Perrone, T, 2013) |
| " Dapagliflozin in combination and as monotherapy was dosed at 5 mg (Study 1) and 10 mg (Study 2)." | 2.77 | Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. ( Hennicken, D; Henry, RR; List, JF; Marmolejo, MH; Murray, AV; Ptaszynska, A, 2012) |
| "Glycemic control in type 2 diabetes generally worsens over time, requiring intensification of therapy." | 2.77 | Glycemic control over 5 years in 4,900 people with type 2 diabetes: real-world diabetes therapy in a clinical trial cohort. ( Best, JD; Davis, TM; Drury, PL; Keech, AC; Kesäniemi, YA; Pardy, C; Scott, R; Taskinen, MR; Voysey, M, 2012) |
| "In people with type 2 diabetes, a dipeptidyl peptidase-4 (DPP-4) inhibitor is one choice as second-line treatment after metformin, with basal insulin recommended as an alternative." | 2.77 | Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. ( Aschner, P; Chan, J; Dain, MP; Echtay, A; Fonseca, V; Owens, DR; Picard, S; Pilorget, V; Wang, E, 2012) |
| " Average increases in insulin dosage with exenatide and placebo were 13 U/d and 20 U/d." | 2.76 | Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. ( Bergenstal, RM; Buse, JB; Glass, LC; Heilmann, CR; Hoogwerf, BJ; Kwan, AY; Lewis, MS; Rosenstock, J, 2011) |
| " The dosage of acarbose and glibenclamide was 50 mg TID and 2." | 2.76 | Effects of acarbose versus glibenclamide on glycemic excursion and oxidative stress in type 2 diabetic patients inadequately controlled by metformin: a 24-week, randomized, open-label, parallel-group comparison. ( Lee, IT; Lee, WJ; Lin, SD; Lin, SY; Sheu, WH; Su, SL; Tseng, YH; Tu, ST; Wang, JS, 2011) |
| "The objective of this study was to assess the efficacy and safety of metformin at the dosage of 2,500 mg/day in the treatment of obese women with PCOS and also to evaluate its effect on weight, hormones, and lipid profile." | 2.75 | Metformin 2,500 mg/day in the treatment of obese women with polycystic ovary syndrome and its effect on weight, hormones, and lipid profile. ( Aghahosseini, M; Aleyaseen, A; Kashani, L; Moddaress-Hashemi, S; Mofid, B; Safdarian, L, 2010) |
| "Intensive treatment of patients with Type 2 diabetes mellitus (T2DM) from the moment of diagnosis facilitates β-cell recovery." | 2.75 | Benefits of self-monitoring blood glucose in the management of new-onset Type 2 diabetes mellitus: the St Carlos Study, a prospective randomized clinic-based interventional study with parallel groups. ( Abad, R; Calle-Pascual, AL; Del Valle, L; Durán, A; Fernández, M; Martín, P; Pérez, N; Runkle, I; Sanz, MF, 2010) |
| "Few studies have given suggestions on appropriate initiation insulin dosage when combined with oral antidiabetic drugs (OADs)." | 2.75 | Appropriate insulin initiation dosage for insulin-naive type 2 diabetes outpatients receiving insulin monotherapy or in combination with metformin and/or pioglitazone. ( Dong, JJ; Liao, L; Mou, YR; Qiu, LL; Yang, M; Zhao, JJ, 2010) |
| " The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74." | 2.74 | Fifty-two-week efficacy and safety of vildagliptin vs. glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy. ( Ahrén, B; Byiers, S; Dejager, S; Ferrannini, E; Fonseca, V; Matthews, D; Shao, Q; Zinman, B, 2009) |
| "Vildagliptin is an effective and well-tolerated treatment option in elderly patients with type 2 diabetes, demonstrating similar improvement in glycaemic control as metformin, with superior GI tolerability." | 2.74 | Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trial. ( Bosi, E; Dejager, S; Schweizer, A, 2009) |
| "The aim of the study was to compare the efficacy and safety of liraglutide in type 2 diabetes mellitus vs placebo and insulin glargine (A21Gly,B31Arg,B32Arg human insulin), all in combination with metformin and glimepiride." | 2.74 | Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. ( Antic, S; Lalic, N; Ravn, GM; Russell-Jones, D; Schmitz, O; Sethi, BK; Simó, R; Vaag, A; Zdravkovic, M, 2009) |
| "Insulin initiation in patients with type 2 diabetes is often delayed because of concerns about injections." | 2.74 | Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: A randomized noninferiority trial. ( Althouse, S; Berclaz, PY; Colon-Vega, G; Ferguson, JA; Gross, JL; Milicevic, Z; Nakano, M; Ortiz-Carasquillo, R; Tobian, JA, 2009) |
| "Metformin is an oral hypoglycaemic agent that improves insulin action in patients with type-2 diabetes." | 2.73 | Effect of adjunct metformin treatment in patients with type-1 diabetes and persistent inadequate glycaemic control. A randomized study. ( Alibegovic, AC; Astrup, AS; Frandsen, M; Hovind, P; Jacobsen, PK; Lund, SS; Parving, HH; Parving, I; Pietraszek, L; Rossing, P; Tarnow, L; Vaag, AA, 2008) |
| "Twenty-eight patients with type 2 diabetes mellitus (HbAlc>7." | 2.73 | Effect of metformin on serum lipoprotein lipase mass levels and LDL particle size in type 2 diabetes mellitus patients. ( Ebisuno, M; Endo, K; Koide, N; Miyashita, Y; Murano, T; Ohira, M; Oyama, T; Saiki, A; Shirai, K; Watanabe, H, 2007) |
| " Compared with placebo, sitagliptin had a neutral effect on body weight and did not significantly increase the risk of hypoglycemia or gastrointestinal adverse events." | 2.73 | Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. ( Alba, M; Amatruda, JM; Chen, Y; Hussain, S; Kaufman, KD; Langdon, RB; Raz, I; Stein, PP; Wu, M, 2008) |
| " Both active treatments were generally well tolerated, with no increased risk of hypoglycaemia or gastrointestinal adverse events compared with placebo." | 2.73 | Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. ( Davies, MJ; Engel, SS; Loeys, T; Scott, R, 2008) |
| "In patients with type 2 diabetes mellitus (T2DM), biomarkers reflecting inflammation and endothelial dysfunction have been linked to cardiovascular disease (CVD biomarkers) and metabolic regulation." | 2.73 | Impact of metformin versus repaglinide on non-glycaemic cardiovascular risk markers related to inflammation and endothelial dysfunction in non-obese patients with type 2 diabetes. ( Frandsen, M; Gram, J; Lund, SS; Parving, HH; Pedersen, O; Schalkwijk, CG; Smidt, UM; Stehouwer, CD; Tarnow, L; Teerlink, T; Vaag, AA; Winther, K, 2008) |
| "Semaglutide is an advantageous choice for the treatment of T2D since it has greater efficacy in reducing glycated hemoglobin and body weight compared with other GLP-1RAs, has demonstrated benefits in reducing major adverse cardiovascular events, and has a favorable profile in special populations (e." | 2.72 | Clinical Perspectives on the Use of Subcutaneous and Oral Formulations of Semaglutide. ( Gallwitz, B; Giorgino, F, 2021) |
| "In type 2 diabetic patients we compared 9 months of combination therapy with insulin glargine and metformin with 9 months of NPH insulin combined with metformin." | 2.72 | Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. ( Hänninen, J; Hardy, K; Hulme, S; Kauppinen-Mäkelin, R; Lahdenperä, S; Lehtonen, R; Levänen, H; McNulty, S; Nikkilä, K; Ryysy, L; Tiikkainen, M; Tulokas, T; Vähätalo, M; Virtamo, H; Yki-Järvinen, H, 2006) |
| "Liraglutide is a promising drug for the treatment of type 2 diabetes." | 2.72 | Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. ( Filipczak, R; Gumprecht, J; Hompesch, M; Le, TD; Nauck, MA; Zdravkovic, M, 2006) |
| "Starting insulin in Type 2 diabetes patients with twice-daily BIAsp 30 plus met can reduce HbA (1c) and mean prandial plasma glucose increment to a greater extent than once-daily glarg plus glim." | 2.72 | Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. ( Kann, PH; Medding, J; Moeller, J; Mokan, M; Mrevlje, F; Regulski, M; Szocs, A; Wascher, T; Zackova, V, 2006) |
| "Sibutramine treatment raised sitting diastolic blood pressure by > or = 5 mmHg in a higher proportion of patients than did placebo (43% with 15 mg/day vs." | 2.71 | A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin. ( McNulty, SJ; Ur, E; Williams, G, 2003) |
| "Mean body weight was unchanged in the rosiglitazone group, while it decreased by 2." | 2.71 | Differential effects of rosiglitazone and metformin on adipose tissue distribution and glucose uptake in type 2 diabetic subjects. ( Hällsten, K; Huupponen, R; Janatuinen, T; Knuuti, J; Lönnqvist, F; Lönnroth, P; Nuutila, P; Parkkola, R; Rönnemaa, T; Viljanen, T; Virtanen, KA, 2003) |
| " Adverse events were reported in only 2." | 2.71 | Efficacy, tolerability and safety of nateglinide in combination with metformin. Results from a study under general practice conditions. ( Lehwalder, D; Schandry, R; Schatz, H; Schoppel, K, 2003) |
| "Thirty-one volunteers with type 2 diabetes mellitus, 16 on dietary therapy and 15 on sulfonylurea monotherapy (SU), were treated with metformin for 12 weeks." | 2.71 | Effect of metformin treatment on multiple cardiovascular disease risk factors in patients with type 2 diabetes mellitus. ( Abbasi, F; Chu, JW; Lamendola, C; Leary, ET; McLaughlin, T; Reaven, GM, 2004) |
| "Weight gain was avoided when MET therapy preceded the addition of TGZ therapy." | 2.71 | Improved glycemic control without weight gain using triple therapy in type 2 diabetes. ( Avilés-Santa, ML; Raskin, P; Strowig, SM, 2004) |
| "Metformin was adjusted up to 2,550 mg/day before insulin therapy was initiated with 5-6 units BIAsp 70/30 twice daily or 10-12 units glargine at bedtime and titrated to target blood glucose (80-110 mg/dl) by algorithm-directed titration." | 2.71 | Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs. ( Allen, E; Bode, B; Gabbay, RA; Garber, A; Hollander, P; Hu, P; Lewin, A; Raskin, P, 2005) |
| "To evaluate the efficacy and safety of two dosage strengths of a single-tablet metformin-glibenclamide (glyburide) combination, compared with the respective monotherapies, in patients with Type 2 diabetes mellitus (DM) inadequately controlled by metformin monotherapy." | 2.70 | Improved glycaemic control with metformin-glibenclamide combined tablet therapy (Glucovance) in Type 2 diabetic patients inadequately controlled on metformin. ( Allavoine, T; Howlett, H; Lehert, P; Marre, M, 2002) |
| "Metformin was tolerated well by the majority of patients." | 2.70 | The effects of metformin on body mass index and glucose tolerance in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes. ( Bursey, D; Freemark, M, 2001) |
| "Therefore, glibenclamide treatment of Type 2 diabetes mellitus may have hazardous cardiovascular effects when used under conditions of ischaemia." | 2.70 | Vascular effects of glibenclamide vs. glimepiride and metformin in Type 2 diabetic patients. ( Abbink, EJ; Jansen van Rosendaal, A; Lutterman, JA; Pickkers, P; Russel, FG; Smits, P; Tack, CJ, 2002) |
| "Obese and overweight type 2 diabetes patients treated with insulin for at least 1 year, and with poor glycaemic control (HbA1c > upper reference level + 2%), were included in a randomised, double-blind, placebo-controlled study." | 2.70 | Long-term glycaemic improvement after addition of metformin to insulin in insulin-treated obese type 2 diabetes patients. ( Hermann, LS; Kalén, J; Katzman, P; Lager, I; Nilsson, A; Norrhamn, O; Sartor, G; Ugander, L, 2001) |
| " In study 2 (n = 14), subjects already established on adjunctive metformin/insulin therapy stopped the metformin component and received 12 weeks of metformin at their baseline dosage (range 1-2." | 2.69 | The effects of metformin on glycemic control and serum lipids in insulin-treated NIDDM patients with suboptimal metabolic control. ( Burke, J; Elkeles, RS; Johnston, DG; Robinson, AC; Robinson, S, 1998) |
| "Defective GS activity in obese NIDDM patients is not secondary to hyperglycemia." | 2.69 | Irreversibility of the defect in glycogen synthase activity in skeletal muscle from obese patients with NIDDM treated with diet and metformin. ( Beck-Nielsen, H; Damsbo, P; Hermann, LS; Hother-Nielsen, O; Vaag, A, 1998) |
| "Metformin is an effective adjunct to insulin therapy in patients with type 2 diabetes." | 2.69 | Effects of metformin in patients with poorly controlled, insulin-treated type 2 diabetes mellitus. A randomized, double-blind, placebo-controlled trial. ( Avilés-Santa, L; Raskin, P; Sinding, J, 1999) |
| "Troglitazone and metformin lower glucose levels in diabetic patients without increasing plasma insulin levels." | 2.69 | A comparison of troglitazone and metformin on insulin requirements in euglycemic intensively insulin-treated type 2 diabetic patients. ( Kruszynska, YT; Mulford, MI; Olefsky, JM; Yu, JG, 1999) |
| " The first three dose levels comprised increasing single-drug therapy (M or G) or primary combination at increasing but low dosage (MGL), and the second three levels were composed of various high-dose combinations, i." | 2.67 | Therapeutic comparison of metformin and sulfonylurea, alone and in various combinations. A double-blind controlled study. ( Bitzén, PO; Hermann, LS; Kjellström, T; Lindgärde, F; Melander, A; Scherstén, B, 1994) |
| "Twenty-two NIDDM patients completed an open randomized cross-over study comparing metformin and glibenclamide over 1 year." | 2.67 | Prospective comparative study in NIDDM patients of metformin and glibenclamide with special reference to lipid profiles. ( Hermann, LS; Karlsson, JE; Sjöstrand, A, 1991) |
| "Metformin was administered and built up to a maximum dosage of 1 g three times daily." | 2.67 | Double-blind evaluation of efficacy and tolerability of metformin in NIDDM. ( Dornan, TL; Heller, SR; Peck, GM; Tattersall, RB, 1991) |
| " The outcomes included changes in HbA1c, FPG, body weight, SBP, DBP and adverse reactions." | 2.66 | Efficacy and safety of dapagliflozin plus saxagliptin vs monotherapy as added to metformin in patients with type 2 diabetes: A meta-analysis. ( Li, M; Song, J; Ying, M; Zhuang, Y, 2020) |
| "Although body weight was unchanged during sulfonylurea/metformin therapy, lean body mass and energy expenditure decreased significantly (p less than 0." | 2.66 | Different effects of insulin and oral antidiabetic agents on glucose and energy metabolism in type 2 (non-insulin-dependent) diabetes mellitus. ( Ekstrand, A; Eriksson, J; Franssila-Kallunki, A; Groop, L; Saloranta, C; Schalin, C; Widén, E, 1989) |
| " Mean initial dosage was 7." | 2.64 | Glipizide in the treatment of maturity-onset diabetes: a multi-centre, out-patient study. ( Fowler, LK, 1978) |
| " The daily dosage of phenformin and metformin was increased at weekly intervals up to 300 mg." | 2.63 | Weight-reducing effect of diguanides in obese non-diabetic women. ( Duncan, LJ; MacCuish, AC; Marshall, A; Munro, JF; Wilson, EM, 1969) |
| "Obesity is one of the main risk factors for type 2 diabetes (T2D), representing a major worldwide health crisis." | 2.61 | Body Weight Considerations in the Management of Type 2 Diabetes. ( Apovian, CM; O'Neil, PM; Okemah, J, 2019) |
| "Dapagliflozin treatment was more cost-effective compared with metformin treatment for Chinese type 2 diabetes patients." | 2.61 | Cost-effectiveness analysis of dapagliflozin treatment versus metformin treatment in Chinese population with type 2 diabetes. ( Cai, X; Chen, Y; Gu, S; Ji, L; Nie, L; Shi, L; Yang, W, 2019) |
| "The majority of patients with type 2 diabetes also have obesity." | 2.58 | Understanding the impact of commonly utilized, non-insulin, glucose-lowering drugs on body weight in patients with type 2 diabetes. ( Dunham, MW; Hurren, KM, 2018) |
| " This meta-analysis revealed the use of dulaglutide as a monotherapy or an add-on to OAM and lispro appeared to be effective and safe for adults with T2DM." | 2.53 | Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review. ( Tong, N; Zhang, L; Zhang, M; Zhang, Y, 2016) |
| "Most patients with type 2 diabetes, who receive monotherapy, are unable to maintain glucose levels with the progress of disease." | 2.53 | Empagliflozin/metformin fixed-dose combination: a review in patients with type 2 diabetes. ( Hu, J; Tan, X; Zhang, S; Zhou, M; Zou, P, 2016) |
| "Preliminary evidence suggests a dose-response relationship between metformin use and increases in height in children and adolescents compared with a control group." | 2.52 | Evaluating the Effects of Metformin Use on Height in Children and Adolescents: A Meta-analysis of Randomized Clinical Trials. ( Boulé, NG; Carson, V; Kuzik, N; Myette-Côté, É; Slater, L, 2015) |
| " RCTs were selected for meta-analysis if (1) they were RCTs comparing DPP-4 inhibitors plus metformin as initial combination therapy or DPP-4 inhibitor monotherapy to metformin monotherapy, (2) duration of treatment was ≥12 weeks and (3) reported data on haemoglobin A1c (HbA1c) change, fasting plasma glucose (FPG) change, weight change, adverse cardiovascular (CV) events, hypoglycaemia or gastrointestinal adverse events (AEs)." | 2.50 | Efficacy and safety of dipeptidyl peptidase-4 inhibitors and metformin as initial combination therapy and as monotherapy in patients with type 2 diabetes mellitus: a meta-analysis. ( Li, L; Liu, C; Wu, D, 2014) |
| "RCTs enrolling subjects with type 2 diabetes inadequately controlled on metformin monotherapy were included." | 2.50 | Dapagliflozin compared with other oral anti-diabetes treatments when added to metformin monotherapy: a systematic review and network meta-analysis. ( Barnett, AH; Goring, S; Hawkins, N; Roudaut, M; Townsend, R; Wood, I; Wygant, G, 2014) |
| " The glucose-dependency of their glucagon-inhibiting and insulin-enhancing effects, together with their weight-sparing properties, make the incretin therapies a logical proposition for use in combination with exogenous basal insulin therapy." | 2.49 | Incretin-based therapy in combination with basal insulin: a promising tactic for the treatment of type 2 diabetes. ( Bain, SC; Damci, T; Dzida, G; Hollander, P; Meneghini, LF; Ross, SA; Vora, J, 2013) |
| " Longer-acting GLP-1 agonists are dosed less frequently, appear to be associated with less nausea, and may be associated with better rates of adherence than shorter-acting agents." | 2.47 | Optimizing outcomes for GLP-1 agonists. ( Freeman, JS, 2011) |
| "Metformin is a cornerstone of oral antidiabetic treatment." | 2.45 | Metformin--the gold standard in type 2 diabetes: what does the evidence tell us? ( Bosi, E, 2009) |
| "Vildagliptin is a potent and selective inhibitor of dipeptidyl peptidase-IV (DPP-4), orally active, that improves glycemic control in patients with type 2 diabetes (T2DM) primarily by enhancing pancreatic (alpha and beta) islet function." | 2.44 | Combination treatment in the management of type 2 diabetes: focus on vildagliptin and metformin as a single tablet. ( Dejager, S; Foley, J; Halimi, S; Minic, B; Schweizer, A, 2008) |
| "However, many antidiabetic treatments increase body weight." | 2.44 | Metformin and body weight. ( Golay, A, 2008) |
| "Obesity is a chronic metabolic disorder that affects one third of American adults." | 2.44 | Pharmacotherapy for obesity. ( Aronne, LJ; Neff, LM, 2007) |
| "The aim of this study was to quantify the effect of a sulphonylurea on glycaemic control and the risk adverse events when incorporated into the treatment regimen of patients with type 2 diabetes inadequately controlled on metformin." | 2.44 | Glycaemic control and adverse events in patients with type 2 diabetes treated with metformin + sulphonylurea: a meta-analysis. ( Belsey, J; Krishnarajah, G, 2008) |
| "Insulin resistance is a condition in which the glycemic response to insulin is less than normal." | 2.42 | Treatment of insulin resistance in diabetes mellitus. ( Banerji, MA; Lebovitz, HE, 2004) |
| "Metformin has been used for over 40 years as an effective glucose-lowering agent in type 2 (noninsulin-dependent) diabetes mellitus." | 2.40 | A risk-benefit assessment of metformin in type 2 diabetes mellitus. ( Bailey, CJ; Howlett, HC, 1999) |
| "Metformin is a commonly used drug of PCOS but few studies on whether metformin can improve the follicle development and ovarian function in PCOS." | 1.91 | Metformin improves polycystic ovary syndrome in mice by inhibiting ovarian ferroptosis. ( Chang, Q; Chen, X; He, R; Hei, C; Li, G; Liang, X; Liu, H; Liu, X; Ouyang, J; Peng, Q; Ren, S; Sun, M; Sun, Y; Wang, C; Wang, Q; Wu, X; Xie, H, 2023) |
| " The adverse events profile was consistent with other glucagon-like peptide-1 receptor agonists (GLP-1 RAs); gastrointestinal adverse events were most frequent in all three studies." | 1.91 | Efficacy and safety of once-weekly efpeglenatide in people with suboptimally controlled type 2 diabetes: The AMPLITUDE-D, AMPLITUDE-L and AMPLITUDE-S randomized controlled trials. ( Aroda, VR; Baek, S; Choi, J; Denkel, K; Espinasse, M; Frias, JP; Guo, H; Ji, L; Lingvay, I; Nguyên-Pascal, ML; Niemoeller, E, 2023) |
| "We aimed to evaluate whether pulmonary fibrosis occurs in type 2 diabetes rat models and whether VD3 can prevent it by inhibiting pyroptosis." | 1.91 | Vitamin D3 alleviates lung fibrosis of type 2 diabetic rats via SIRT3 mediated suppression of pyroptosis. ( Chen, H; Li, M; Li, W; Li, X; Peng, Y; Song, H; Tang, L; Zhang, D; Zhang, Y, 2023) |
| "Metformin is a widely used drug for treating type 2 diabetes and is also used for delaying sexual maturation in girls with precocious puberty." | 1.72 | Metformin treatment of juvenile mice alters aging-related developmental and metabolic phenotypes. ( Bartke, A; Fang, Y; Medina, D; Yuan, R; Zhu, Y, 2022) |
| "Weight loss was 0." | 1.72 | A Health Care Professional Delivered Low Carbohydrate Diet Program Reduces Body Weight, Haemoglobin A1c, Diabetes Medication Use and Cardiovascular Risk Markers-A Single-Arm Intervention Analysis. ( Brinkworth, GD; Taylor, PJ; Thompson, CH; Wycherley, TP, 2022) |
| "Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are serious health concerns for which lifestyle interventions are the only effective first-line treatment." | 1.72 | Combining Dietary Intervention with Metformin Treatment Enhances Non-Alcoholic Steatohepatitis Remission in Mice Fed a High-Fat High-Sucrose Diet. ( Amigó, N; Baiges-Gaya, G; Camps, J; Castañé, H; Jiménez-Franco, A; Joven, J; Rodríguez-Tomàs, E, 2022) |
| "Metformin was administered intragastrically, and aerobic exercise was performed using treadmill with 7-12 m/min, 30-40 min/day, 5 days/week." | 1.62 | Morphological and functional characterization of diabetic cardiomyopathy in db/db mice following exercise, metformin alone, or combination treatments. ( Liu, J; Lu, J; Tang, Q; Wang, X; Zhang, L; Zhang, Y, 2021) |
| "A rat model of PCOS-IR was established using a high-fat diet (49 d) combined with letrozole (1 mg/kg·d, for 28 d)." | 1.62 | Effects of total flavonoids from Eucommia ulmoides Oliv. leaves on polycystic ovary syndrome with insulin resistance model rats induced by letrozole combined with a high-fat diet. ( Li, CX; Li, M; Miao, MS; Peng, MF; Ren, Z; Song, YG; Tian, S, 2021) |
| "Metformin is an antidiabetic drug commonly used in obesity treatment." | 1.56 | Effect of high-fat diet-induced obesity on thyroid gland structure in female rats and the possible ameliorating effect of metformin therapy. ( El-Sayed, SM; Ibrahim, HM, 2020) |
| "Rats treated with metformin showed a significant improvement in the aforementioned parameters." | 1.56 | Combined treatments with metformin and phosphodiesterase inhibitors alleviate nonalcoholic fatty liver disease in high-fat diet fed rats: a comparative study. ( Abdel-Latif, RG; El-Deen, RM; Heeba, GH; Khalifa, MMA, 2020) |
| "In this study, mice with type 2 diabetes mellitus (T2DM) induced by high-fat diet were used to investigate the antidiabetic effect and mechanism of action of peanut skin extract (PSE)." | 1.56 | Peanut skin extract ameliorates the symptoms of type 2 diabetes mellitus in mice by alleviating inflammation and maintaining gut microbiota homeostasis. ( Osada, H; Pan, W; Qi, J; Wu, Q; Xiang, L; Yoshida, M, 2020) |
| "Metformin treatment of HFD rats reduced fasting insulin and free fatty acid concentrations and lowered body weight and adiposity." | 1.51 | Metformin improves vascular and metabolic insulin action in insulin-resistant muscle. ( Attrill, E; Betik, AC; Bradley, EA; Hu, D; Keske, MA; Premilovac, D; Rattigan, S; Richards, SM, 2019) |
| "Bariatric surgery leads to type 2 diabetes mellitus (T2DM) remission, but recurrence can ensue afterwards." | 1.51 | Long-term diabetes outcomes after bariatric surgery-managing medication withdrawl. ( Belo, S; Carvalho, D; Freitas, P; Magalhães, D; Neves, JS; Oliveira, SC; Pedro, J; Souteiro, P; Varela, A, 2019) |
| "NAFLD is prevalent in patients with type 2 diabetes mellitus (T2DM), yet only preliminary evidence are available on the effect of anti-diabetic agents to NAFLD in T2DM patients." | 1.51 | Reply. ( Weng, J, 2019) |
| "The hepatoprotective effect of Cs on NAFLD may possibly be due to its antioxidant effect." | 1.51 | Hepatoprotective effects of Cassia semen ethanol extract on non-alcoholic fatty liver disease in experimental rat. ( Fang, N; Guo, Y; Liu, Y; Meng, Y, 2019) |
| " The easy and convenient oncedaily dosing should be customized according to patient needs and glycaemic profiles." | 1.51 | Expert Opinion: Use of sodium glucose co-transporter type-2 inhibitors in South Asian population -The Pakistan perspective. ( Aamir, AH; Ahmad, I; Ishtiaq, O; Islam, N; Jawa, A; Khan, K; Khan, KM; Mahar, SA; Naseer, N; Qureshi, FM; Raza, SA, 2019) |
| "Metformin is an anti-hyperglycemic drug widely used for the treatment of insulin resistance and glucose intolerance and is currently considered for preventing large-for-gestational-age (LGA) offspring in pregnant women affected by obesity or diabetes." | 1.51 | Maternal Metformin Treatment Improves Developmental and Metabolic Traits of IUGR Fetuses. ( Astiz, S; Encinas, T; Garcia-Contreras, C; Gonzalez-Bulnes, A; Heras-Molina, A; Pesantez-Pacheco, JL; Torres-Rovira, L; Vazquez-Gomez, M, 2019) |
| "A rodent model of type 2 diabetes (30 mg/kg streptozotocin and high-fat feeding in male Sprague-Dawley rats) was used to assess 12 weeks of co-treatment with a sodium-glucose cotransporter 2 inhibitor (SGLT2i) and exercise (EX; treadmill running) on glycemic control and exercise capacity." | 1.51 | The combination of exercise training and sodium-glucose cotransporter-2 inhibition improves glucose tolerance and exercise capacity in a rodent model of type 2 diabetes. ( Beebe, DA; Braun, B; Esler, WP; Gorgoglione, MF; Hamilton, KL; Linden, MA; Miller, BF; Ross, TT, 2019) |
| "Polycystic ovary syndrome is one of the most common causes of female infertility, affecting 5-10% of the population." | 1.51 | Ocimum kilimandscharicum L. restores ovarian functions in letrozole - induced Polycystic Ovary Syndrome (PCOS) in rats: Comparison with metformin. ( AbdelMaksoud, S; El-Bahy, AA; Handoussa, H; Khaled, N; Radwan, R, 2019) |
| "Metformin treatment decreased the expression of IL-1β and IL-6 in epididymal fat, which was correlated with the abundance of various bacterial genera." | 1.48 | Modulation of the gut microbiota by metformin improves metabolic profiles in aged obese mice. ( An, J; Kim, J; Kim, K; Kong, H; Lee, CK; Lee, H; Lee, S; Lee, Y; Song, Y, 2018) |
| "Men with type 2 diabetes (T2D) and obesity are often characterised by low testosterone (T)." | 1.48 | Short-term combined treatment with exenatide and metformin is superior to glimepiride combined metformin in improvement of serum testosterone levels in type 2 diabetic patients with obesity. ( Hao, M; Kuang, HY; Li, BW; Ma, XF; Pan, J; Shao, N; Wu, WH; Yu, XY; Yu, YM; Zhang, HJ, 2018) |
| "To analyze the efficacy and safety of replacing sitagliptin with canagliflozin in patients with type 2 diabetes (T2D) and poor metabolic control despite treatment with sitagliptin in combination with metformin and/or gliclazide." | 1.48 | Efficacy and safety of replacing sitagliptin with canagliflozin in real-world patients with type 2 diabetes uncontrolled with sitagliptin combined with metformin and/or gliclazide: The SITA-CANA Switch Study. ( Garcia de Lucas, MD; Gómez Huelgas, R; Olalla Sierra, J; Pérez Belmonte, LM; Suárez Tembra, M, 2018) |
| "Data on 25,386 patients with type 2 diabetes, newly treated with a DPP4 inhibitor (2007-2013), were sourced from a United Kingdom general practice database via the Health Improvement Network database." | 1.43 | Determinants of Glycemic Response to Add-On Therapy with a Dipeptidyl Peptidase-4 Inhibitor: A Retrospective Cohort Study Using a United Kingdom Primary Care Database. ( Donnelly, R; Idris, I; Mamza, J; Mehta, R, 2016) |
| "Metformin was treated daily for 14 weeks in a high-fat dieting C57BL/6J mice." | 1.43 | Metformin Prevents Fatty Liver and Improves Balance of White/Brown Adipose in an Obesity Mouse Model by Inducing FGF21. ( Byun, JK; Cho, ML; Choi, JY; Jeong, JH; Jhun, JY; Kim, EK; Kim, JK; Lee, SH; Lee, SY, 2016) |
| " In STZ-induced diabetic rats the long-term administration of metformin normalized reduced PON1 activity assayed toward paraoxon (+42." | 1.43 | The paraoxonase 1 (PON1), platelet-activating factor acetylohydrolase (PAF-AH) and dimethylarginine dimethylaminohydrolase (DDAH) activity in the metformin treated normal and diabetic rats. ( Bełtowski, J; Czechowska, G; Jamroz-Wiśniewska, A; Korolczuk, A; Marciniak, S; Wójcicka, G, 2016) |
| "A significant decrement of hyperinsulinemia, triglyceridemia, serum IL6 and oxidised LDL were observed at the end of the study." | 1.43 | Metformin preconditioned adipose derived mesenchymal stem cells is a better option for the reversal of diabetes upon transplantation. ( Bhonde, RR; Shree, N, 2016) |
| "The recent type 2 diabetes American Diabetes Association/European Association for the Study of Diabetes (ADA/EASD) position statement suggested insulin is the most effective glucose-lowering therapy, especially when glycated haemoglobin (HbA1c) is very high." | 1.42 | Is insulin the most effective injectable antihyperglycaemic therapy? ( Buse, JB; Diamant, M; Donsmark, M; Furber, S; Han, J; MacConell, L; Maggs, D; Peters, A; Russell-Jones, D, 2015) |
| "Metformin (Met), which is an insulin-sensitizer, decreases insulin resistance and fasting insulin levels." | 1.42 | Intracerebroventricular metformin decreases body weight but has pro-oxidant effects and decreases survival. ( Brochier, AW; de Assis, AM; de Carvalho, AK; Gnoatto, J; Haas, CB; Hansel, G; Muller, AP; Oses, JP; Portela, LV; Zimmer, ER, 2015) |
| "Vildagliptin treatment with or without metformin was generally well tolerated." | 1.42 | Clinical effectiveness and safety of vildagliptin in >19 000 patients with type 2 diabetes: the GUARD study. ( Abou Jaoude, E; Al-Arouj, M; DiTommaso, S; Fawwad, A; Latif, ZA; Orabi, A; Rosales, R; Shah, P; Vaz, J, 2015) |
| "Treatment with liraglutide in randomized controlled trials is associated with significant reductions in glycated hemoglobin (HbA1c) and weight loss in type 2 diabetes patients." | 1.42 | Correlation between baseline characteristics and clinical outcomes in a large population of diabetes patients treated with liraglutide in a real-world setting in Italy. ( Balzano, S; Bax, G; Bettio, M; Bonsembiante, B; Brun, E; Cardone, C; Confortin, L; D'Ambrosio, M; Da Tos, V; Dal Frà, MG; Dal Pos, M; Ferrari, M; Frison, V; Gallo, A; Lamonica, M; Lapolla, A; Marangoni, A; Marin, N; Masin, M; Mesturino, CA; Panebianco, G; Pianta, A; Piarulli, F; Rocchini, P; Sartore, G; Simioni, N; Simoncini, M; Strazzabosco, M; Tadiotto, F; Zen, F, 2015) |
| "Type 2 diabetes is a chronic disease that cannot be treated adequately using the known monotherapies, especially when the disease progresses to an advanced stage." | 1.42 | Combination therapy with oleanolic acid and metformin as a synergistic treatment for diabetes. ( Abdelkader, D; Chen, Y; Hassan, W; Liu, J; Sun, H; Wang, X, 2015) |
| "Treatment with liraglutide resulted in mean decreases in hemoglobin A1c (HbA1c) of -1." | 1.42 | Add-On Treatment with Liraglutide Improves Glycemic Control in Patients with Type 2 Diabetes on Metformin Therapy. ( Brunetti, A; Capula, C; Chiefari, E; Foti, D; Greco, M; Liguori, R; Oliverio, R; Puccio, L; Pullano, V; Tirinato, D; Vero, A; Vero, R, 2015) |
| "Treatment of type 2 diabetes with glucagon-like peptide-1 (GLP-1) receptor agonists may be limited by gastrointestinal side effects (GISE) in some patients." | 1.42 | The influence of age and metformin treatment status on reported gastrointestinal side effects with liraglutide treatment in type 2 diabetes. ( Blann, AD; Gupta, PS; Ryder, RE; Thong, KY, 2015) |
| "The metformin treatment of Wistar rats with obesity induced by high-fat diet was carried out for 2 months (daily dose of 200 mg/kg)." | 1.42 | [THE EFFECTS OF LONG-TERM METFORMIN TREATMENT ON THE ACTIVITY OF ADENYLYL CYCLASE SYSTEM AND NO-SYNTHASES IN THE BRAIN AND THE MYOCARDIUM OF RATS WITH OBESITY]. ( Bondareva, VM; Derkach, KV; Ignatieva, PA; Kuznetsova, LA; Sharova, TS; Shpakov, AO, 2015) |
| "To determine how many ambulatory older adults with chronic kidney disease receive medications that are contraindicated or dosed excessively given their level of renal function." | 1.42 | Use of Renally Inappropriate Medications in Older Veterans: A National Study. ( Chang, F; Miao, Y; O'Hare, AM; Steinman, MA, 2015) |
| "Treatment with metformin was associated with a significant weight reduction (P = 0·033), which resulted from a decrease in BF% (P = 0·044) but was not associated with changes in android and gynoid depots." | 1.40 | Changes in adiponectin level and fat distribution in patients with type 2 diabetes. ( Dziwura-Ogonowska, J; Iskierska, K; Miazgowski, T; Safranow, K; Widecka, K, 2014) |
| "Metformin treatment was similarly evaluated and found not to have adverse effects on pancreas." | 1.40 | Characterization of the exocrine pancreas in the male Zucker diabetic fatty rat model of type 2 diabetes mellitus following 3 months of treatment with sitagliptin. ( Cunningham, C; Dey, M; Forest, T; Frederick, C; Holder, D; Prahalada, S; Smith, A; Yao, X, 2014) |
| "Metformin is a widely prescribed drug for the treatment of type 2 diabetes." | 1.40 | Metformin impairs mitochondrial function in skeletal muscle of both lean and diabetic rats in a dose-dependent manner. ( Ciapaite, J; Nicolay, K; Prompers, JJ; van den Broek, NM; Wessels, B, 2014) |
| "Weight gain was associated with a significant increase in all-cause costs of $3400 per year compared with the weight-neutral cohort; however, differences in T2DM-specific costs and discontinuation rates did not reach significance levels." | 1.40 | Economic implications of weight change in patients with type 2 diabetes mellitus. ( Bell, K; D'Souza, A; Graham, J; Lamerato, L; Parasuraman, S; Raju, A; Shah, M, 2014) |
| "Metformin was administered during gestation from E0." | 1.40 | Prenatal metformin exposure in a maternal high fat diet mouse model alters the transcriptome and modifies the metabolic responses of the offspring. ( Ailanen, L; Eerola, K; Heinäniemi, M; Koulu, M; Pesonen, U; Ruohonen, ST; Salomäki, H; Vähätalo, LH, 2014) |
| "Metformin was used as a standard drug." | 1.39 | Anti-diabetic effect of Murraya koenigii (L) and Olea europaea (L) leaf extracts on streptozotocin induced diabetic rats. ( Al-Olayan, EM; Almarhoon, ZM; Daghestani, MH; El-Amin, M; Elobeid, MA; Hassan, ZK; Merghani, NM; Omer, SA; Virk, P, 2013) |
| "Metformin also inhibited the growth of pancreatic cancer xenografts when administered orally (2." | 1.39 | Metformin inhibits the growth of human pancreatic cancer xenografts. ( Eibl, G; Kisfalvi, K; Moro, A; Rozengurt, E; Sinnett-Smith, J, 2013) |
| "Metformin initiation was associated with a lower risk of kidney function decline or death compared to sulfonylureas, which which appeared to be independent of changes in BMI, SBP, and glycated hemoglobin over time." | 1.39 | Kidney function decline in metformin versus sulfonylurea initiators: assessment of time-dependent contribution of weight, blood pressure, and glycemic control. ( Greevy, RA; Griffin, MR; Grijalva, CG; Hung, AM; Liu, X; Murff, HJ; Roumie, CL, 2013) |
| "Metformin has been reported to increase the expression of the glucagon-like peptide-1 (GLP-1) receptor in pancreatic beta cells in a peroxisome proliferator-activated receptor (PPAR)-α-dependent manner." | 1.39 | Effect of the combination of metformin and fenofibrate on glucose homeostasis in diabetic Goto-Kakizaki rats. ( Cho, YM; Kang, GH; Oh, TJ; Park, KS; Shin, JY, 2013) |
| " We conclude that this treatment intensification approach may be useful, efficient, and safe in daily clinical practice for patients with type 2 diabetes." | 1.39 | Efficacy and safety of insulin glargine added to a fixed-dose combination of metformin and a dipeptidyl peptidase-4 inhibitor: results of the GOLD observational study. ( Bramlage, P; Pegelow, K; Seufert, J, 2013) |
| " This open-label, prospective, multicentre, post-marketing surveillance study was conducted to investigate the efficacy and safety of nateglinide in combination with metformin in Chinese patients with type 2 diabetes (T2DM)." | 1.39 | Nateglinide in combination with metformin in Chinese patients with type 2 diabetes mellitus: a post-marketing surveillance study. ( Wang, L; Yang, JK, 2013) |
| "Nonalcoholic fatty liver disease (NAFLD), one of chronic liver diseases, seems to be rising as the obesity epidemic continues." | 1.38 | Synthesis and biological evaluation of 5-benzylidenepyrimidine-2,4,6(1H,3H,5H)-trione derivatives for the treatment of obesity-related nonalcoholic fatty liver disease. ( Chen, J; Chen, L; Huang, L; Lai, H; Liang, X; Liu, J; Ma, L; Pei, H; Peng, A; Ran, Y; Sang, Y; Wei, Y; Xiang, M; Xie, C, 2012) |
| "Metformin treatment improved these alterations." | 1.38 | Improvement of metabolic parameters and vascular function by metformin in obese non-diabetic rats. ( Akamine, EH; Carvalho, MH; Filgueira, FP; Fortes, ZB; Hagihara, GN; Lobato, NS; Pariz, JR; Tostes, RC, 2012) |
| "Both bortezomib and metformin have been proposed as potential therapeutics in TSC." | 1.38 | Therapeutic trial of metformin and bortezomib in a mouse model of tuberous sclerosis complex (TSC). ( Auricchio, N; Kwiatkowski, DJ; Malinowska, I; Manning, BD; Shaw, R, 2012) |
| "Insulin resistance has been shown to be associated with cardiac sympathovagal imbalance, myocardial dysfunction, and cardiac mitochondrial dysfunction." | 1.38 | Cardioprotective effects of metformin and vildagliptin in adult rats with insulin resistance induced by a high-fat diet. ( Apaijai, N; Chattipakorn, N; Chattipakorn, SC; Pintana, H, 2012) |
| "Rosiglitazone treatment reduced insulin resistance and partially restored β-cell mass in animals with reduced β-cell mass at birth." | 1.37 | Effect of combining rosiglitazone with either metformin or insulin on β-cell mass and function in an animal model of Type 2 diabetes characterized by reduced β-cell mass at birth. ( Gerstein, HC; Hettinga, BP; Holloway, AC, 2011) |
| "Approximately 40% of patients with type 2 diabetes may progress to nephropathy and a good metabolic control can prevent the development of diabetic renal injury." | 1.37 | Insulin and metformin may prevent renal injury in young type 2 diabetic Goto-Kakizaki rats. ( da Cunha, FX; Louro, TM; Matafome, PN; Nunes, EC; Seiça, RM, 2011) |
| "non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes are associated with dyslipidaemia, inflammation and oxidative stress." | 1.37 | Metformin and atorvastatin combination further protect the liver in type 2 diabetes with hyperlipidaemia. ( Amaral, C; Cipriano, A; Crisóstomo, J; Louro, T; Matafome, P; Monteiro, P; Nunes, E; Rodrigues, L; Seiça, R, 2011) |
| "Advanced HF (heart failure) is associated with altered substrate metabolism." | 1.37 | Effect of metformin therapy on cardiac function and survival in a volume-overload model of heart failure in rats. ( Benada, O; Benes, J; Cervenka, L; Drahota, Z; Houstek, J; Kazdova, L; Kolar, M; Kopecky, J; Kovarova, N; Medrikova, D; Melenovsky, V; Petrak, J; Sedmera, D; Skaroupkova, P; Strnad, H; Vrbacky, M, 2011) |
| "Treatment with metformin started at the age of 3 months increased mean life span by 14% and maximum life span by 1 month." | 1.37 | If started early in life, metformin treatment increases life span and postpones tumors in female SHR mice. ( Anisimov, VN; Berstein, LM; Egormin, PA; Kovalenko, IG; Piskunova, TS; Popovich, IG; Poroshina, TE; Semenchenko, AV; Tyndyk, ML; Yurova, MN; Zabezhinski, MA, 2011) |
| "05) reduced hyperglycemia, glibenclamide or metformin combined with honey produced significantly much lower blood glucose (8." | 1.37 | Glibenclamide or metformin combined with honey improves glycemic control in streptozotocin-induced diabetic rats. ( Erejuwa, OO; Gurtu, S; Salleh, MS; Sirajudeen, KN; Sulaiman, SA; Wahab, MS, 2011) |
| "Metformin pre-treatment also reduced endothelial cell damage in ferrous chloride induced thrombosis in carotid arteries." | 1.37 | Investigation of the potential effects of metformin on atherothrombotic risk factors in hyperlipidemic rats. ( Bhadada, SV; Dhamecha, PS; Ghatak, SB; Panchal, SJ, 2011) |
| "Metformin was administered i." | 1.37 | The effect of metformin on the myocardial tolerance to ischemia-reperfusion injury in the rat model of diabetes mellitus type II. ( Bairamov, A; Galagudza, M; Grineva, E; Kravchuk, E; Vlasov, T, 2011) |
| "Metformin is an anti-type II diabetes drug that has anti-inflammatory and anti-oxidant properties, can bring about mitochondrial biogenesis and has been shown to attenuate pathology in mouse models of Huntington's disease and multiple sclerosis." | 1.37 | Metformin treatment has no beneficial effect in a dose-response survival study in the SOD1(G93A) mouse model of ALS and is harmful in female mice. ( Kaneb, HM; Rahmani-Kondori, N; Sharp, PS; Wells, DJ, 2011) |
| "Metformin is a first-line drug for the treatment of type 2 diabetes (T2D) and is often prescribed in combination with other drugs to control a patient's blood glucose level and achieve their HbA1c goal." | 1.36 | Toxicity and toxicokinetics of metformin in rats. ( Chism, JP; Jordan, HL; Melich, DH; Nold, JB; Polli, JW; Quaile, MP; Rhodes, MC; Smith, GA, 2010) |
| "Metformin treatment significantly decreased the blood glucose levels from 15." | 1.36 | Metformin normalizes type 2 diabetes-induced decrease in cell proliferation and neuroblast differentiation in the rat dentate gyrus. ( Choi, JW; Hwang, IK; Joo, EJ; Kim, IY; Seong, JK; Shin, JH; Won, MH; Yoon, YS, 2010) |
| "Body weight was significantly reduced in the metformin group compared with control during the middle of the study, despite similar weekly food intake." | 1.36 | Metformin supplementation and life span in Fischer-344 rats. ( Allison, DB; Elam, CF; Ingram, DK; Lane, MA; Mattison, JA; Roth, GS; Smith, DL, 2010) |
| "Metformin treatment also improved hyperleptinemia, whereas pioglitazone was ineffective." | 1.36 | Metformin reduces body weight gain and improves glucose intolerance in high-fat diet-fed C57BL/6J mice. ( Hirasawa, Y; Ito, M; Kyuki, K; Matsui, Y; Sugiura, T; Toyoshi, T, 2010) |
| "We hypothesized that hyperinsulinemia precedes the development of insulin resistance and increased adiposity in these mice with a defective adipoinsular axis." | 1.36 | Hyperinsulinemia precedes insulin resistance in mice lacking pancreatic beta-cell leptin signaling. ( Covey, SD; Donald, C; Gray, SL; Jetha, A; Kieffer, TJ, 2010) |
| "The animal model of type 2 diabetes with hepatic fibrosis was successfully made." | 1.36 | [Effect of metformin on the formation of hepatic fibrosis in type 2 diabetic rats]. ( Chen, BN; Du, GH; Qiang, GF; Shi, LL; Xuan, Q; Yang, XY; Zhang, HA; Zhang, L, 2010) |
| "Obese patients with type 2 diabetes and impaired glucose tolerance are at increased risk of development of cardiovascular diseases." | 1.35 | Effects of basal insulin analog and metformin on glycaemia control and weight as risk factors for endothelial dysfunction. ( Ascić-Buturović, B; Kacila, M, 2008) |
| "Metformin is an efficient curative and preventive treatment for sleep apnea, suggesting that insulin resistance modifies the ventilatory drive independently of obesity." | 1.34 | Sleep apnea is induced by a high-fat diet and reversed and prevented by metformin in non-obese rats. ( Delanaud, S; Dewasmes, G; Geloen, A; Libert, JP; Petitjean, M; Ramadan, W; Wiernsperger, N, 2007) |
| "Pioglitazone treatment restored MCD activity to non-diabetic level and improved the restrained fatty acid metabolism in myocardial and skeletal muscles caused by insulin-resistant diabetic status." | 1.33 | Tissue-specific regulation of malonyl-CoA decarboxylase activity in OLETF rats. ( Ahn, CW; Cha, BS; Kim, HJ; Kim, SK; Lee, HC; Lee, YJ; Park, CW; Shim, WS; Zhao, ZS, 2006) |
| "Metformin treatment resulted in a modest loss of weight." | 1.33 | Stability of body weight in type 2 diabetes. ( Chaudhry, ZW; Gannon, MC; Nuttall, FQ, 2006) |
| "Metformin treatment significantly improved hyperandrogenism, menstrual cyclicity, body weight, and insulin resistance independent of GNAS1 genotype." | 1.33 | The CC genotype of the GNAS T393C polymorphism is associated with obesity and insulin resistance in women with polycystic ovary syndrome. ( Frey, UH; Hahn, S; Janssen, OE; Mann, K; Siffert, W; Tan, S, 2006) |
| "Patients with type 2 diabetes and complete HbA(1c) (A1C) data and treated with metformin or sulfonylurea monotherapy for at least three visits before receiving dual oral therapy were included (n = 644)." | 1.33 | Long-term efficacy of metformin therapy in nonobese individuals with type 2 diabetes. ( Constantino, MI; Molyneaux, LM; Ong, CR; Twigg, SM; Yue, DK, 2006) |
| "Metformin-HCl was administered to 14-day-old broiler chickens at either 300 or 600 mg/kg per day in the drinking water for 10 d while monitoring BW and feed intake." | 1.32 | Hypoglycemia and reduced feed intake in broiler chickens treated with metformin. ( Ashwell, CM; McMurtry, JP, 2003) |
| "Type 2 diabetes can present as diabetic ketoacidosis in obese adolescent subjects." | 1.32 | Type 2 diabetes presenting as diabetic ketoacidosis in adolescence. ( Cox, J; Elkeles, RS; Elwig, C; Poulter, C; Valabhji, J; Watson, M, 2003) |
| "Metformin is an efficacious long-term use drug in poorly controlled type 2 diabetes patients, either in monotherapy or in combination." | 1.32 | Long-term efficacy of steady-dose metformin in type 2 diabetes mellitus: a retrospective study. ( Czupryniak, L; Drzewoski, J, 2003) |
| "Metformin was present in very low or undetectable concentrations in the plasma of four of the infants who were studied." | 1.31 | Transfer of metformin into human milk. ( Hackett, LP; Hale, TW; Ilett, KF; Kohan, R; Kristensen, JH, 2002) |
| "There is no known treatment for fatty liver, a ubiquitous cause of chronic liver disease." | 1.31 | Metformin reverses fatty liver disease in obese, leptin-deficient mice. ( Chuckaree, C; Diehl, AM; Kuhajda, F; Lin, HZ; Ronnet, G; Yang, SQ, 2000) |
| " Eight-week-old male C57BL/Ks (db/db) mice were sorted into control and exercise groups and dosed daily for 4 weeks with vehicle, metformin (150 mg/kg/d), or acarbose (40 mg/kg/d)." | 1.31 | Exercise adds to metformin and acarbose efficacy in db/db mice. ( Reed, MJ; Tang, T, 2001) |
| "There is no established treatment for steatohepatitis in patients who are not alcoholics." | 1.31 | Metformin in non-alcoholic steatohepatitis. ( Bianchi, G; Brizi, M; Marchesini, G; Melchionda, N; Tomassetti, S; Zoli, M, 2001) |
| "Metformin appears to be an effective medication for the treatment of T2DM in children, but did not seem to be a sufficient long-term monotherapy in our protocol, which required euglycemia for insulin withdrawal." | 1.31 | Treatment of type 2 diabetes mellitus in children and adolescents. ( Brosnan, PG; Hardin, DS; Zuhri-Yafi, MI, 2002) |
| "Commonly used drugs for type 2 diabetes are not ideal." | 1.30 | Review of management of type 2 diabetes mellitus. ( Greenaway, TM; Peterson, GM; Randall, CT; Vial, JH; Yap, WS, 1998) |
| "Metformin-treated rats gained significantly less weight." | 1.29 | Prevention of hyperglycemia in the Zucker diabetic fatty rat by treatment with metformin or troglitazone. ( Burant, CF; Polonsky, KS; Pugh, W; Sreenan, S; Sturis, J, 1996) |
| "Metformin treatment did not lead to an increase of the patients body weight." | 1.29 | [The effect of metformin on lactate levels in type II diabetes]. ( Cacáková, V; Perusicová, J; Richtrová, A, 1996) |
| "A total of 40 NIDDM patients were examined (24 females and 16 males) with a mean age of 55." | 1.29 | [Comparison of two treatment models in type-II diabetic patients with poor metabolic control: Preformed combination of glibenclamide 2,5 mg + metformin 400 mg or mono-therapy with sulfonylurea at maximal doses? An evaluation at six months]. ( Cavallo, P; D'Argenzio, R; Merante, D; Morelli, A, 1996) |
| "Metformin markedly reduced also the hyperinsulinemia of the obese animals without altering their plasma glucose or pancreatic insulin content which may reflect an improved insulin sensitivity after metformin treatment." | 1.28 | Subchronic treatment with metformin produces anorectic effect and reduces hyperinsulinemia in genetically obese Zucker rats. ( Huupponen, R; Koulu, M; Pesonen, U; Rouru, J, 1992) |
| "Gliclazide is a suitable oral hypoglycaemic agent for use in the obese diabetic who cannot be controlled by diet alone." | 1.27 | A comparison of treatment with metformin and gliclazide in patients with non-insulin-dependent diabetes. ( Frier, BM; Kay, JW; McAlpine, CH; McAlpine, LG; Storer, AM; Waclawski, ER, 1988) |
| " Side effects were more common with metformin, particularly in the higher dosage and overall control of the diabetes was achieved in the same proportion of patients (33%)." | 1.26 | A comparison of phenformin and metformin in the treatment of maturity onset diabetes. ( Cairns, SA; Hartog, M; Marshall, AJ; Shalet, S, 1977) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 34 (5.00) | 18.7374 |
| 1990's | 44 (6.47) | 18.2507 |
| 2000's | 163 (23.97) | 29.6817 |
| 2010's | 359 (52.79) | 24.3611 |
| 2020's | 80 (11.76) | 2.80 |
| Authors | Studies |
|---|---|
| Manickam, M | 1 |
| Ramanathan, M | 1 |
| Jahromi, MA | 1 |
| Chansouria, JP | 1 |
| Ray, AB | 1 |
| Carney, JR | 1 |
| Krenisky, JM | 1 |
| Williamson, RT | 1 |
| Luo, J | 4 |
| Carlson, TJ | 1 |
| Hsu, VL | 1 |
| Moswa, JL | 1 |
| Inman, WD | 1 |
| Jolad, SD | 1 |
| King, SR | 1 |
| Cooper, R | 1 |
| Papi Reddy, K | 1 |
| Singh, AB | 2 |
| Puri, A | 1 |
| Srivastava, AK | 2 |
| Narender, T | 1 |
| Ma, L | 2 |
| Xie, C | 1 |
| Ran, Y | 1 |
| Liang, X | 2 |
| Huang, L | 2 |
| Pei, H | 1 |
| Chen, J | 2 |
| Liu, J | 4 |
| Sang, Y | 1 |
| Lai, H | 1 |
| Peng, A | 1 |
| Xiang, M | 1 |
| Wei, Y | 1 |
| Chen, L | 5 |
| Zhang, JQ | 1 |
| Li, SM | 1 |
| Ma, X | 2 |
| Zhong, G | 1 |
| Chen, R | 1 |
| Li, XS | 1 |
| Zhu, GF | 1 |
| Zhou, B | 1 |
| Guo, B | 1 |
| Wu, HS | 1 |
| Tang, L | 2 |
| Li, X | 7 |
| Xu, Q | 1 |
| Li, C | 1 |
| Wang, L | 3 |
| Jiang, B | 1 |
| Shi, D | 2 |
| Xing, C | 1 |
| Lv, B | 1 |
| Zhao, H | 2 |
| Wang, D | 2 |
| He, B | 1 |
| Figueiredo, BS | 1 |
| Ferreira, FBD | 1 |
| Barbosa, AM | 1 |
| Dos Santos, C | 1 |
| Ortsäter, H | 1 |
| Rafacho, A | 1 |
| Cui, J | 1 |
| Song, L | 1 |
| Wang, R | 2 |
| Hu, S | 1 |
| Yang, Z | 1 |
| Zhang, Z | 2 |
| Sun, B | 1 |
| Cui, W | 1 |
| Lu, J | 2 |
| Zhang, L | 6 |
| Wang, X | 5 |
| Zhang, Y | 6 |
| Tang, Q | 2 |
| Zhu, Y | 2 |
| Fang, Y | 1 |
| Medina, D | 1 |
| Bartke, A | 1 |
| Yuan, R | 1 |
| Gao, L | 4 |
| Huang, H | 1 |
| Zhang, N | 2 |
| Fu, Y | 1 |
| Zhu, D | 3 |
| Bi, Y | 3 |
| Feng, W | 2 |
| Abdalla, MA | 1 |
| Shah, N | 1 |
| Deshmukh, H | 1 |
| Sahebkar, A | 1 |
| Östlundh, L | 1 |
| Al-Rifai, RH | 1 |
| Atkin, SL | 3 |
| Sathyapalan, T | 1 |
| Cheng, L | 1 |
| Fu, Q | 1 |
| Zhou, L | 2 |
| Fan, Y | 2 |
| Liu, F | 2 |
| Zhang, X | 5 |
| Lin, W | 1 |
| Wu, X | 2 |
| Bakhtyukov, AA | 1 |
| Derkach, KV | 2 |
| Sorokoumov, VN | 1 |
| Stepochkina, AM | 1 |
| Romanova, IV | 1 |
| Morina, IY | 1 |
| Zakharova, IO | 1 |
| Bayunova, LV | 1 |
| Shpakov, AO | 2 |
| Green, CJ | 1 |
| Marjot, T | 1 |
| Walsby-Tickle, J | 1 |
| Charlton, C | 1 |
| Cornfield, T | 1 |
| Westcott, F | 1 |
| Pinnick, KE | 1 |
| Moolla, A | 1 |
| Hazlehurst, JM | 1 |
| McCullagh, J | 1 |
| Tomlinson, JW | 1 |
| Hodson, L | 1 |
| Yu, XJ | 1 |
| Chen, YM | 1 |
| Liu, XJ | 2 |
| Bai, XJ | 1 |
| Liu, KL | 1 |
| Fu, LY | 1 |
| Gao, HL | 1 |
| Sun, TZ | 1 |
| Shi, XL | 1 |
| Qi, J | 2 |
| Li, Y | 6 |
| Kang, YM | 1 |
| Ferrannini, E | 5 |
| Niemoeller, E | 3 |
| Dex, T | 1 |
| Servera, S | 1 |
| Mari, A | 1 |
| Ding, Y | 1 |
| Liu, Y | 3 |
| Qu, Y | 1 |
| Lin, M | 1 |
| Dong, F | 1 |
| Cao, L | 1 |
| Lin, S | 1 |
| Kellerer, M | 1 |
| Kaltoft, MS | 2 |
| Lawson, J | 1 |
| Nielsen, LL | 1 |
| Strojek, K | 1 |
| Tabak, Ö | 1 |
| Jacob, S | 2 |
| Vadher, K | 1 |
| Patel, H | 1 |
| Mody, R | 1 |
| Levine, JA | 2 |
| Hoog, M | 1 |
| Cheng, AY | 1 |
| Pantalone, KM | 1 |
| Sapin, H | 1 |
| Huh, Y | 1 |
| Kim, YS | 1 |
| Frias, JP | 4 |
| Choi, J | 2 |
| Rosenstock, J | 9 |
| Popescu, L | 1 |
| Muehlen-Bartmer, I | 1 |
| Baek, S | 2 |
| Ghasemian, F | 1 |
| Esmaeilnezhad, S | 1 |
| Nirwan, N | 1 |
| Vohora, D | 1 |
| Seo, DH | 1 |
| Suh, YJ | 1 |
| Cho, Y | 1 |
| Ahn, SH | 1 |
| Seo, S | 1 |
| Hong, S | 1 |
| Lee, YH | 2 |
| Choi, YJ | 1 |
| Lee, E | 1 |
| Kim, SH | 1 |
| Dupak, R | 1 |
| Hrnkova, J | 1 |
| Simonova, N | 1 |
| Kovac, J | 1 |
| Ivanisova, E | 1 |
| Kalafova, A | 1 |
| Schneidgenova, M | 1 |
| Prnova, MS | 1 |
| Brindza, J | 1 |
| Tokarova, K | 1 |
| Capcarova, M | 1 |
| Brinkworth, GD | 1 |
| Wycherley, TP | 1 |
| Taylor, PJ | 1 |
| Thompson, CH | 1 |
| Cheng, Z | 3 |
| Su, B | 3 |
| Su, X | 3 |
| Song, W | 3 |
| Guo, Y | 5 |
| Liao, L | 4 |
| Chen, X | 7 |
| Li, J | 5 |
| Tan, X | 6 |
| Xu, F | 4 |
| Pang, S | 3 |
| Wang, K | 3 |
| Ye, J | 5 |
| Wang, Y | 4 |
| Sun, J | 3 |
| Ji, L | 7 |
| Carter, EW | 3 |
| Vadari, HS | 3 |
| Stoll, S | 3 |
| Rogers, B | 3 |
| Resnicow, K | 3 |
| Heisler, M | 3 |
| Herman, WH | 3 |
| Kim, HM | 3 |
| McEwen, LN | 3 |
| Volpp, KG | 3 |
| Kullgren, JT | 3 |
| Baiges-Gaya, G | 1 |
| Rodríguez-Tomàs, E | 1 |
| Castañé, H | 1 |
| Jiménez-Franco, A | 1 |
| Amigó, N | 1 |
| Camps, J | 1 |
| Joven, J | 1 |
| Peng, Q | 1 |
| Ouyang, J | 1 |
| Wang, Q | 2 |
| Ren, S | 1 |
| Xie, H | 1 |
| Wang, C | 3 |
| Sun, Y | 2 |
| Liu, H | 2 |
| Hei, C | 1 |
| Sun, M | 1 |
| Chang, Q | 1 |
| Liu, X | 3 |
| Li, G | 4 |
| He, R | 1 |
| Cai, H | 1 |
| Chen, Q | 3 |
| Duan, Y | 1 |
| Zhao, Y | 3 |
| Kamble, P | 1 |
| Desai, S | 1 |
| Bhonde, R | 1 |
| Sanap, A | 1 |
| Shimpi, J | 1 |
| Kumbhar, R | 1 |
| Kokani, M | 1 |
| Kharat, A | 1 |
| Aroda, VR | 3 |
| Nguyên-Pascal, ML | 1 |
| Denkel, K | 1 |
| Espinasse, M | 1 |
| Guo, H | 1 |
| Lingvay, I | 1 |
| Zhang, SY | 1 |
| Bruce, K | 1 |
| Danaei, Z | 1 |
| Li, RJW | 1 |
| Barros, DR | 1 |
| Kuah, R | 1 |
| Lim, YM | 1 |
| Mariani, LH | 1 |
| Cherney, DZ | 1 |
| Chiu, JFM | 1 |
| Reich, HN | 1 |
| Lam, TKT | 1 |
| Liu, Z | 1 |
| Zhang, K | 1 |
| Zhang, J | 2 |
| Wang, F | 2 |
| Zhou, Y | 1 |
| Wang, M | 2 |
| Zhou, S | 1 |
| Li, M | 8 |
| Wang, S | 2 |
| Patel, T | 1 |
| Nageeta, F | 1 |
| Sohail, R | 1 |
| Butt, TS | 1 |
| Ganesan, S | 1 |
| Madhurita, F | 1 |
| Ahmed, M | 1 |
| Zafar, M | 1 |
| Zafar, W | 1 |
| Zaman, MU | 1 |
| Varrassi, G | 1 |
| Khatri, M | 1 |
| Kumar, S | 1 |
| Zhang, D | 1 |
| Peng, Y | 2 |
| Song, H | 1 |
| Chen, H | 6 |
| Li, W | 2 |
| Zakaraia, HG | 1 |
| Salem, HF | 1 |
| Mostafa, MAA | 1 |
| Ali, AM | 1 |
| Rabea, H | 1 |
| Xie, Z | 1 |
| Hu, J | 2 |
| Gu, H | 1 |
| Małecki, MT | 1 |
| Batterham, RL | 1 |
| Sattar, N | 5 |
| Rodríguez, Á | 2 |
| Bergman, BK | 1 |
| Wang, H | 3 |
| Ghimpeteanu, G | 1 |
| Lee, CJ | 1 |
| Ajiboye, BO | 1 |
| Dada, S | 1 |
| Fatoba, HO | 1 |
| Lawal, OE | 1 |
| Oyeniran, OH | 1 |
| Adetuyi, OY | 1 |
| Olatunde, A | 1 |
| Taher, M | 1 |
| Khotib, J | 1 |
| Susanti, D | 1 |
| Oyinloye, BE | 1 |
| Bradley, EA | 1 |
| Premilovac, D | 1 |
| Betik, AC | 1 |
| Hu, D | 1 |
| Attrill, E | 1 |
| Richards, SM | 1 |
| Rattigan, S | 1 |
| Keske, MA | 1 |
| Chen, W | 1 |
| Li, P | 2 |
| Wang, G | 1 |
| Chen, Y | 5 |
| Wang, B | 4 |
| Chen, M | 3 |
| Lipscombe, LL | 1 |
| El-Sayed, SM | 1 |
| Ibrahim, HM | 1 |
| Zinman, B | 3 |
| Buse, JB | 3 |
| Cariou, B | 2 |
| Harris, SB | 1 |
| Hoff, ST | 1 |
| Pedersen, KB | 1 |
| Tarp-Johansen, MJ | 1 |
| Araki, E | 1 |
| Zhang, W | 1 |
| Xu, JH | 1 |
| Yu, T | 1 |
| Chen, QK | 1 |
| Walton, RG | 1 |
| Dungan, CM | 1 |
| Long, DE | 1 |
| Tuggle, SC | 1 |
| Kosmac, K | 1 |
| Peck, BD | 1 |
| Bush, HM | 1 |
| Villasante Tezanos, AG | 1 |
| McGwin, G | 1 |
| Windham, ST | 1 |
| Ovalle, F | 1 |
| Bamman, MM | 1 |
| Kern, PA | 1 |
| Peterson, CA | 1 |
| Taneja, V | 1 |
| Yang, D | 1 |
| Yan, J | 2 |
| Weng, J | 3 |
| Zekarias, K | 1 |
| Davey, C | 1 |
| Seaquist, E | 1 |
| Blazina, I | 1 |
| Selph, S | 1 |
| Bassols, J | 2 |
| Martínez-Calcerrada, JM | 2 |
| Osiniri, I | 1 |
| Díaz-Roldán, F | 2 |
| Xargay-Torrent, S | 2 |
| Mas-Parés, B | 2 |
| Dorado-Ceballos, E | 1 |
| Prats-Puig, A | 2 |
| Carreras-Badosa, G | 2 |
| de Zegher, F | 4 |
| Ibáñez, L | 4 |
| López-Bermejo, A | 3 |
| Coll, AP | 1 |
| Taskar, P | 1 |
| Rimmington, D | 1 |
| Patel, S | 1 |
| Tadross, JA | 1 |
| Cimino, I | 1 |
| Yang, M | 2 |
| Welsh, P | 2 |
| Virtue, S | 1 |
| Goldspink, DA | 1 |
| Miedzybrodzka, EL | 1 |
| Konopka, AR | 1 |
| Esponda, RR | 1 |
| Huang, JT | 1 |
| Tung, YCL | 1 |
| Rodriguez-Cuenca, S | 1 |
| Tomaz, RA | 1 |
| Harding, HP | 1 |
| Melvin, A | 1 |
| Yeo, GSH | 1 |
| Preiss, D | 2 |
| Vidal-Puig, A | 1 |
| Vallier, L | 1 |
| Nair, KS | 1 |
| Wareham, NJ | 1 |
| Ron, D | 1 |
| Gribble, FM | 1 |
| Reimann, F | 1 |
| Savage, DB | 1 |
| Allan, BB | 1 |
| O'Rahilly, S | 1 |
| Cao, G | 1 |
| Yi, W | 1 |
| Li, L | 3 |
| Cao, X | 1 |
| Vilsbøll, T | 1 |
| Ekholm, E | 1 |
| Johnsson, E | 6 |
| Garcia-Sanchez, R | 4 |
| Dronamraju, N | 1 |
| Jabbour, SA | 3 |
| Lind, M | 1 |
| Singh, R | 1 |
| Bansal, Y | 1 |
| Sodhi, RK | 1 |
| Singh, DP | 1 |
| Bishnoi, M | 1 |
| Kondepudi, KK | 1 |
| Medhi, B | 1 |
| Kuhad, A | 1 |
| Heeba, GH | 1 |
| El-Deen, RM | 1 |
| Abdel-Latif, RG | 1 |
| Khalifa, MMA | 1 |
| Lawal, SK | 1 |
| Adeniji, AA | 1 |
| Sulaiman, SO | 1 |
| Akajewole, MM | 1 |
| Buhari, MO | 1 |
| Osinubi, AA | 1 |
| Saad, ZA | 1 |
| Khodeer, DM | 1 |
| Zaitone, SA | 1 |
| Ahmed, AAM | 1 |
| Moustafa, YM | 1 |
| Harada, N | 1 |
| Chung, E | 1 |
| Elmassry, MM | 1 |
| Kottapalli, P | 1 |
| Kottapalli, KR | 1 |
| Kaur, G | 1 |
| Dufour, JM | 1 |
| Wright, K | 1 |
| Ramalingam, L | 1 |
| Moustaid-Moussa, N | 1 |
| Hamood, AN | 1 |
| Shen, CL | 1 |
| Zhang, S | 2 |
| Tu, H | 1 |
| Yao, J | 1 |
| Le, J | 1 |
| Jiang, Z | 2 |
| Zhang, R | 1 |
| Huo, P | 1 |
| Lei, X | 2 |
| Palliyaguru, DL | 1 |
| Minor, RK | 1 |
| Mitchell, SJ | 1 |
| Palacios, HH | 1 |
| Licata, JJ | 1 |
| Ward, TM | 1 |
| Abulwerdi, G | 1 |
| Elliott, P | 1 |
| Westphal, C | 1 |
| Ellis, JL | 1 |
| Sinclair, DA | 1 |
| Price, NL | 1 |
| Bernier, M | 1 |
| de Cabo, R | 1 |
| Papaetis, GS | 1 |
| Filippou, PK | 1 |
| Constantinidou, KG | 1 |
| Stylianou, CS | 1 |
| Shin, Y | 1 |
| Moon, JH | 1 |
| Chin, HJ | 1 |
| Lim, S | 2 |
| Day, EA | 1 |
| Ford, RJ | 1 |
| Smith, BK | 1 |
| Mohammadi-Shemirani, P | 1 |
| Morrow, MR | 1 |
| Gutgesell, RM | 1 |
| Lu, R | 1 |
| Raphenya, AR | 1 |
| Kabiri, M | 1 |
| McArthur, AG | 1 |
| McInnes, N | 1 |
| Hess, S | 1 |
| Paré, G | 1 |
| Gerstein, HC | 2 |
| Steinberg, GR | 1 |
| Xiang, L | 1 |
| Wu, Q | 1 |
| Osada, H | 1 |
| Yoshida, M | 1 |
| Pan, W | 1 |
| Larsen, AH | 1 |
| Wiggers, H | 1 |
| Dollerup, OL | 1 |
| Jespersen, NR | 1 |
| Hansson, NH | 1 |
| Frøkiær, J | 1 |
| Brøsen, K | 1 |
| Nørrelund, H | 1 |
| Bøtker, HE | 1 |
| Møller, N | 1 |
| Jessen, N | 1 |
| Zhuang, Y | 1 |
| Song, J | 1 |
| Ying, M | 1 |
| Wang, DD | 1 |
| Li, ZP | 1 |
| Shin, AC | 1 |
| Balasubramanian, P | 1 |
| Suryadevara, P | 1 |
| Zyskowski, J | 1 |
| Herdt, TH | 1 |
| MohanKumar, SMJ | 1 |
| MohanKumar, PS | 1 |
| Li, D | 2 |
| Zou, H | 1 |
| Yin, P | 1 |
| He, J | 1 |
| Shao, S | 1 |
| Yang, Y | 2 |
| Yu, X | 1 |
| Guo, W | 1 |
| Tian, W | 1 |
| Lin, L | 1 |
| Xu, X | 1 |
| Previate, C | 1 |
| Malta, A | 1 |
| Miranda, RA | 1 |
| Martins, IP | 1 |
| Pavanello, A | 1 |
| de Oliveira, JC | 1 |
| Prates, KV | 1 |
| Alves, VS | 1 |
| Francisco, FA | 1 |
| Moreira, VM | 1 |
| Matiusso, CCI | 1 |
| de Moraes, AMP | 1 |
| Mathias, PCF | 1 |
| Franco, CCDS | 1 |
| Inzucchi, SE | 1 |
| Davies, MJ | 2 |
| Khunti, K | 4 |
| Trivedi, P | 1 |
| George, JT | 1 |
| Zwiener, I | 1 |
| Johansen, OE | 1 |
| Luo, C | 1 |
| Huang, HX | 1 |
| Mao, XY | 1 |
| Zhou, HH | 1 |
| Liu, ZQ | 1 |
| He, S | 1 |
| Shi, J | 1 |
| Hong, L | 1 |
| Liu, S | 1 |
| Yuan, X | 1 |
| Jiang, S | 2 |
| Smits, MM | 1 |
| Fluitman, KS | 1 |
| Herrema, H | 1 |
| Davids, M | 1 |
| Kramer, MHH | 1 |
| Groen, AK | 1 |
| Belzer, C | 1 |
| de Vos, WM | 1 |
| Cahen, DL | 1 |
| Nieuwdorp, M | 1 |
| van Raalte, DH | 1 |
| Peng, MF | 1 |
| Tian, S | 1 |
| Song, YG | 1 |
| Li, CX | 1 |
| Miao, MS | 1 |
| Ren, Z | 1 |
| Simanenkova, A | 1 |
| Minasian, S | 1 |
| Karonova, T | 1 |
| Vlasov, T | 2 |
| Timkina, N | 1 |
| Shpilevaya, O | 1 |
| Khalzova, A | 1 |
| Shimshilashvili, A | 1 |
| Timofeeva, V | 1 |
| Samsonov, D | 1 |
| Borshchev, Y | 1 |
| Galagudza, M | 2 |
| Anderson, K | 1 |
| Kelsberg, G | 1 |
| Safranek, S | 1 |
| Grissi, M | 1 |
| Boudot, C | 1 |
| Assem, M | 1 |
| Candellier, A | 1 |
| Lando, M | 1 |
| Poirot-Leclercq, S | 1 |
| Boullier, A | 1 |
| Bennis, Y | 1 |
| Lenglet, G | 1 |
| Avondo, C | 1 |
| Lalau, JD | 1 |
| Choukroun, G | 1 |
| Massy, ZA | 1 |
| Kamel, S | 1 |
| Chillon, JM | 1 |
| Hénaut, L | 1 |
| Lian, J | 1 |
| Fu, J | 3 |
| Charbonnel, B | 2 |
| Cooper, A | 1 |
| Gomes, MB | 1 |
| Leigh, P | 1 |
| Nicolucci, A | 2 |
| Rathmann, W | 1 |
| Shestakova, MV | 2 |
| Siddiqui, A | 1 |
| Tang, F | 1 |
| Watada, H | 2 |
| Yeh, KC | 1 |
| Yeh, TK | 1 |
| Huang, CY | 1 |
| Hu, CB | 1 |
| Wang, MH | 1 |
| Huang, YW | 1 |
| Chou, LH | 1 |
| Ho, HH | 1 |
| Song, JS | 1 |
| Hsu, T | 1 |
| Jiaang, WT | 1 |
| Chao, YS | 1 |
| Chen, CT | 1 |
| Wolf, VLW | 1 |
| Breder, I | 1 |
| de Carvalho, LSF | 1 |
| Soares, AAS | 1 |
| Cintra, RM | 1 |
| Barreto, J | 1 |
| Munhoz, DB | 1 |
| Kimura-Medorima, ST | 1 |
| Nadruz, W | 1 |
| Guerra-Júnior, G | 1 |
| Quinaglia, T | 1 |
| Muscelli, E | 1 |
| Sposito, AC | 1 |
| Saxena, AR | 1 |
| Gorman, DN | 1 |
| Esquejo, RM | 1 |
| Bergman, A | 1 |
| Chidsey, K | 1 |
| Buckeridge, C | 1 |
| Griffith, DA | 1 |
| Kim, AM | 1 |
| Gallwitz, B | 2 |
| Giorgino, F | 1 |
| Mika, K | 1 |
| Szafarz, M | 1 |
| Bednarski, M | 1 |
| Kuder, K | 1 |
| Szczepańska, K | 1 |
| Pociecha, K | 1 |
| Pomierny, B | 1 |
| Kieć-Kononowicz, K | 1 |
| Sapa, J | 1 |
| Kotańska, M | 1 |
| Horvath, G | 1 |
| Kis, G | 1 |
| Kekesi, G | 1 |
| Büki, A | 1 |
| Adlan, LG | 1 |
| Szűcs, E | 1 |
| Heni, HE | 1 |
| Benyhe, S | 1 |
| Petrocelli, JJ | 1 |
| Mahmassani, ZS | 1 |
| Fix, DK | 1 |
| Montgomery, JA | 1 |
| Reidy, PT | 1 |
| McKenzie, AI | 1 |
| de Hart, NM | 1 |
| Ferrara, PJ | 1 |
| Kelley, JJ | 1 |
| Eshima, H | 1 |
| Funai, K | 1 |
| Drummond, MJ | 1 |
| Gómez-Vilarrubla, A | 1 |
| Puerto-Carranza, E | 1 |
| Cigrovski Berković, M | 1 |
| Herman Mahečić, D | 1 |
| Gradišer, M | 1 |
| Bilić-Ćurčić, I | 1 |
| Sharma, A | 1 |
| Yin, C | 1 |
| Xiao, Y | 1 |
| Færch, K | 1 |
| Amadid, H | 1 |
| Nielsen, LB | 1 |
| Ried-Larsen, M | 1 |
| Karstoft, K | 1 |
| Persson, F | 1 |
| Jørgensen, ME | 1 |
| O'Connor, EA | 1 |
| Evans, CV | 1 |
| Burda, BU | 1 |
| Walsh, ES | 1 |
| Eder, M | 1 |
| Lozano, P | 1 |
| Riediger, ND | 1 |
| Lukianchuk, V | 1 |
| Roulette, J | 1 |
| Lix, LM | 1 |
| Elliott, L | 1 |
| Bruce, SG | 1 |
| Brown, RE | 1 |
| Gupta, N | 1 |
| Aronson, R | 2 |
| Kenawy, S | 1 |
| Hegazy, R | 1 |
| Hassan, A | 1 |
| El-Shenawy, S | 1 |
| Gomaa, N | 1 |
| Zaki, H | 1 |
| Attia, A | 1 |
| Forcato, S | 1 |
| Novi, DRBDS | 1 |
| Costa, NO | 1 |
| Borges, LI | 1 |
| Góes, MLM | 1 |
| Ceravolo, GS | 2 |
| Gerardin, DCC | 2 |
| Han, K | 1 |
| Bose, S | 1 |
| Wang, JH | 1 |
| Lim, SK | 1 |
| Chin, YW | 1 |
| Kim, YM | 1 |
| Choi, HS | 1 |
| Kim, H | 1 |
| Rodgers, LR | 1 |
| Weedon, MN | 1 |
| Henley, WE | 1 |
| Hattersley, AT | 1 |
| Shields, BM | 1 |
| Yu, M | 1 |
| Brunt, KV | 1 |
| Milicevic, Z | 2 |
| Varnado, O | 1 |
| Boye, KS | 1 |
| Suzuki, L | 1 |
| Kanazawa, A | 1 |
| Uzawa, H | 1 |
| Osonoi, Y | 1 |
| Masuyama, A | 1 |
| Azuma, K | 1 |
| Takeno, K | 1 |
| Takayanagi, N | 1 |
| Sato, J | 1 |
| Someya, Y | 1 |
| Komiya, K | 1 |
| Goto, H | 1 |
| Mita, T | 1 |
| Ikeda, F | 1 |
| Ogihara, T | 1 |
| Shimizu, T | 1 |
| Ohmura, C | 1 |
| Saito, M | 1 |
| Osonoi, T | 1 |
| Lee, H | 2 |
| Lee, Y | 1 |
| Kim, J | 1 |
| An, J | 1 |
| Lee, S | 1 |
| Kong, H | 1 |
| Song, Y | 1 |
| Lee, CK | 1 |
| Kim, K | 1 |
| Guja, C | 2 |
| Hardy, E | 5 |
| Ahmed, A | 2 |
| Öhman, P | 2 |
| Beysel, S | 1 |
| Unsal, IO | 1 |
| Kizilgul, M | 1 |
| Caliskan, M | 1 |
| Ucan, B | 1 |
| Cakal, E | 1 |
| Chakravarty, A | 1 |
| Rastogi, M | 1 |
| Dhankhar, P | 1 |
| Bell, KF | 1 |
| Prado Correia, LE | 1 |
| de Almeida, BC | 1 |
| de Jesus Simões, M | 1 |
| Abi Haidar, M | 2 |
| Berguio Vidotti, D | 1 |
| Silva, I | 1 |
| Siskind, D | 1 |
| Friend, N | 1 |
| Russell, A | 1 |
| McGrath, JJ | 1 |
| Lim, C | 1 |
| Patterson, S | 1 |
| Flaws, D | 1 |
| Stedman, T | 1 |
| Moudgil, V | 1 |
| Sardinha, S | 1 |
| Suetani, S | 1 |
| Kisely, S | 2 |
| Winckel, K | 1 |
| Baker, A | 1 |
| Eckel, RH | 1 |
| Koh, KK | 1 |
| Jabbour, S | 1 |
| Samman, FS | 1 |
| Elaidy, SM | 1 |
| Essawy, SS | 1 |
| Hassan, MS | 1 |
| Shao, N | 1 |
| Yu, XY | 1 |
| Yu, YM | 1 |
| Li, BW | 1 |
| Pan, J | 1 |
| Wu, WH | 1 |
| Zhang, HJ | 1 |
| Ma, XF | 1 |
| Hao, M | 1 |
| Kuang, HY | 1 |
| Gamad, N | 1 |
| Malik, S | 1 |
| Suchal, K | 1 |
| Vasisht, S | 1 |
| Tomar, A | 1 |
| Arava, S | 1 |
| Arya, DS | 1 |
| Bhatia, J | 1 |
| Vidigal, CB | 1 |
| Novi, DRBS | 1 |
| Moura, KF | 1 |
| Picinin, R | 1 |
| Montagnini, BG | 1 |
| Silva, RNOD | 1 |
| da Silva, MDV | 1 |
| de Andrade, FG | 1 |
| Akamine, EH | 2 |
| Garcia de Lucas, MD | 1 |
| Pérez Belmonte, LM | 1 |
| Suárez Tembra, M | 1 |
| Olalla Sierra, J | 1 |
| Gómez Huelgas, R | 1 |
| Guo, Q | 1 |
| Zhang, H | 3 |
| Zhao, Z | 2 |
| Luo, Y | 3 |
| Cao, W | 1 |
| Zhu, R | 1 |
| Gan, H | 1 |
| Zuo, Z | 1 |
| Shi, C | 1 |
| Guo, J | 2 |
| Zhong, S | 2 |
| de Lima, EA | 1 |
| de Sousa, LGO | 1 |
| de S Teixeira, AA | 1 |
| Marshall, AG | 1 |
| Zanchi, NE | 1 |
| Neto, JCR | 1 |
| Hurren, KM | 1 |
| Dunham, MW | 1 |
| Wilding, J | 2 |
| Godec, T | 1 |
| Pocock, S | 1 |
| Fox, R | 1 |
| Smeeth, L | 1 |
| Clauson, P | 1 |
| Fenici, P | 1 |
| Hammar, N | 1 |
| Medina, J | 1 |
| Scheen, AJ | 2 |
| Mourya, A | 1 |
| Akhtar, A | 1 |
| Ahuja, S | 1 |
| Sah, SP | 1 |
| Kumar, A | 1 |
| Al-Damry, NT | 1 |
| Attia, HA | 1 |
| Al-Rasheed, NM | 2 |
| Mohamad, RA | 1 |
| Al-Amin, MA | 1 |
| Dizmiri, N | 1 |
| Atteya, M | 1 |
| Patel, R | 1 |
| Shah, G | 1 |
| Qian, D | 1 |
| Zhang, T | 1 |
| Zheng, P | 1 |
| Liang, Z | 1 |
| Xie, J | 3 |
| Jiang, J | 2 |
| Situ, B | 1 |
| Loves, S | 1 |
| van Groningen, L | 1 |
| Filius, M | 1 |
| Mekking, M | 1 |
| Brandon, T | 1 |
| Tack, CJ | 3 |
| Hermus, A | 1 |
| de Boer, H | 1 |
| Ostrovskaya, RU | 1 |
| Ivanov, SV | 1 |
| Voronin, MV | 1 |
| Ozerova, IV | 1 |
| Zolotov, NN | 1 |
| Seredenin, SB | 1 |
| Mathieu, C | 2 |
| Saraiva, GL | 1 |
| Yao, B | 1 |
| Kuang, H | 1 |
| Yang, X | 3 |
| Huang, Q | 1 |
| Hong, T | 2 |
| Dou, J | 2 |
| Yang, W | 4 |
| Qin, G | 1 |
| Yuan, H | 1 |
| Xiao, X | 1 |
| Luo, S | 1 |
| Shan, Z | 1 |
| Deng, H | 1 |
| Tan, Y | 1 |
| Xu, W | 1 |
| Zeng, L | 1 |
| Kang, Z | 1 |
| Claßen, M | 1 |
| Apovian, CM | 1 |
| Okemah, J | 1 |
| O'Neil, PM | 1 |
| Solymár, M | 1 |
| Ivic, I | 1 |
| Pótó, L | 1 |
| Hegyi, P | 1 |
| Garami, A | 1 |
| Hartmann, P | 1 |
| Pétervári, E | 1 |
| Czopf, L | 1 |
| Hussain, A | 1 |
| Gyöngyi, Z | 1 |
| Sarlós, P | 1 |
| Simon, M | 1 |
| Mátrai, P | 1 |
| Bérczi, B | 1 |
| Balaskó, M | 1 |
| Lentferink, YE | 1 |
| Knibbe, CAJ | 1 |
| van der Vorst, MMJ | 1 |
| Watson, LE | 1 |
| Phillips, LK | 1 |
| Wu, T | 1 |
| Bound, MJ | 1 |
| Checklin, HL | 1 |
| Grivell, J | 1 |
| Jones, KL | 1 |
| Clifton, PM | 2 |
| Horowitz, M | 1 |
| Rayner, CK | 1 |
| Gu, T | 1 |
| Ma, J | 1 |
| Zhang, Q | 3 |
| Zhu, L | 1 |
| Xu, L | 1 |
| Cheng, J | 1 |
| Shi, B | 1 |
| Shao, J | 1 |
| Sun, Z | 1 |
| Zemel, MB | 1 |
| Kolterman, O | 1 |
| Rinella, M | 1 |
| Vuppalanchi, R | 1 |
| Flores, O | 1 |
| Barritt, AS | 1 |
| Siddiqui, M | 1 |
| Chalasani, N | 1 |
| Eltonsy, S | 1 |
| Dufour Doiron, M | 1 |
| Simard, P | 1 |
| Jose, C | 1 |
| Sénéchal, M | 1 |
| Bouchard, DR | 1 |
| LeBlanc, R | 1 |
| Bélanger, M | 1 |
| Cai, X | 1 |
| Shi, L | 1 |
| Gu, S | 1 |
| Nie, L | 1 |
| Souteiro, P | 1 |
| Belo, S | 1 |
| Magalhães, D | 1 |
| Pedro, J | 1 |
| Neves, JS | 1 |
| Oliveira, SC | 1 |
| Freitas, P | 1 |
| Varela, A | 1 |
| Carvalho, D | 1 |
| Zhao, J | 2 |
| Li, Q | 3 |
| Meng, Y | 2 |
| Zuo, L | 1 |
| Yang, T | 1 |
| Yang, R | 1 |
| Qi, S | 1 |
| Yang, K | 1 |
| Xu, Y | 2 |
| Liu, C | 2 |
| Upala, S | 1 |
| Fang, N | 1 |
| Kulkarni, S | 1 |
| Xavier, D | 1 |
| George, B | 1 |
| Umesh, S | 1 |
| Fathima, S | 1 |
| Bantwal, G | 1 |
| Ussery, E | 1 |
| Bridges, KN | 1 |
| Pandelides, Z | 1 |
| Kirkwood, AE | 1 |
| Guchardi, J | 1 |
| Holdway, D | 1 |
| Derkach, K | 1 |
| Zakharova, I | 1 |
| Zorina, I | 1 |
| Bakhtyukov, A | 1 |
| Romanova, I | 1 |
| Bayunova, L | 1 |
| Shpakov, A | 1 |
| Asai, A | 1 |
| Shuto, Y | 1 |
| Nagao, M | 1 |
| Kawahara, M | 1 |
| Miyazawa, T | 1 |
| Sugihara, H | 1 |
| Oikawa, S | 1 |
| Mohan, M | 1 |
| Al-Talabany, S | 1 |
| McKinnie, A | 1 |
| Mordi, IR | 1 |
| Singh, JSS | 1 |
| Gandy, SJ | 1 |
| Baig, F | 1 |
| Hussain, MS | 1 |
| Bhalraam, U | 1 |
| Khan, F | 1 |
| Choy, AM | 1 |
| Matthew, S | 1 |
| Houston, JG | 1 |
| Struthers, AD | 1 |
| George, J | 1 |
| Lang, CC | 1 |
| Raza, SA | 1 |
| Aamir, AH | 1 |
| Jawa, A | 1 |
| Qureshi, FM | 1 |
| Ahmad, I | 1 |
| Khan, KM | 1 |
| Khan, K | 1 |
| Naseer, N | 1 |
| Islam, N | 1 |
| Ishtiaq, O | 1 |
| Mahar, SA | 1 |
| Cusi, K | 1 |
| Garcia-Contreras, C | 1 |
| Vazquez-Gomez, M | 1 |
| Pesantez-Pacheco, JL | 1 |
| Torres-Rovira, L | 1 |
| Heras-Molina, A | 1 |
| Encinas, T | 1 |
| Astiz, S | 1 |
| Gonzalez-Bulnes, A | 1 |
| Chen, Z | 1 |
| Linden, MA | 1 |
| Ross, TT | 1 |
| Beebe, DA | 1 |
| Gorgoglione, MF | 1 |
| Hamilton, KL | 1 |
| Miller, BF | 1 |
| Braun, B | 1 |
| Esler, WP | 1 |
| Perl, S | 1 |
| Moustafa, HAM | 1 |
| El Wakeel, LM | 1 |
| Halawa, MR | 1 |
| Sabri, NA | 1 |
| El-Bahy, AZ | 1 |
| Singab, AN | 1 |
| Ge, CX | 1 |
| Xu, MX | 1 |
| Qin, YT | 1 |
| Gu, TT | 1 |
| Lou, DS | 1 |
| Hu, LF | 1 |
| Wang, BC | 1 |
| Tan, J | 1 |
| Khaled, N | 1 |
| El-Bahy, AA | 1 |
| Radwan, R | 1 |
| Handoussa, H | 1 |
| AbdelMaksoud, S | 1 |
| Akinnuga, AM | 1 |
| Bamidele, O | 1 |
| Adewumi, AJ | 1 |
| Meneghini, L | 1 |
| Kesavadev, J | 1 |
| Demissie, M | 1 |
| Nazeri, A | 1 |
| Hollander, P | 5 |
| Giampietro, O | 1 |
| Giampietro, C | 1 |
| Bartola, LD | 1 |
| Masoni, MC | 1 |
| Matteucci, E | 1 |
| El-Amin, M | 1 |
| Virk, P | 1 |
| Elobeid, MA | 1 |
| Almarhoon, ZM | 1 |
| Hassan, ZK | 1 |
| Omer, SA | 1 |
| Merghani, NM | 1 |
| Daghestani, MH | 1 |
| Al-Olayan, EM | 1 |
| Salomäki, H | 2 |
| Vähätalo, LH | 2 |
| Laurila, K | 1 |
| Jäppinen, NT | 1 |
| Penttinen, AM | 1 |
| Ailanen, L | 2 |
| Ilyasizadeh, J | 1 |
| Pesonen, U | 5 |
| Koulu, M | 5 |
| Kisfalvi, K | 1 |
| Moro, A | 1 |
| Sinnett-Smith, J | 1 |
| Eibl, G | 1 |
| Rozengurt, E | 1 |
| Li, H | 1 |
| Guo, X | 1 |
| Hu, R | 1 |
| Zhu, Z | 1 |
| Feng, Y | 1 |
| Shen, L | 2 |
| Xu, D | 1 |
| Ruan, K | 1 |
| Cong, W | 1 |
| Maffioli, P | 7 |
| Fogari, E | 3 |
| D'Angelo, A | 3 |
| Perrone, T | 1 |
| Derosa, G | 7 |
| Wilding, JP | 1 |
| Woo, V | 2 |
| Soler, NG | 1 |
| Pahor, A | 1 |
| Sugg, J | 5 |
| Rohwedder, K | 6 |
| Parikh, S | 6 |
| Nauck, M | 3 |
| del Prato, S | 5 |
| Meier, JJ | 1 |
| Durán-García, S | 3 |
| Elze, M | 1 |
| Parikh, SJ | 2 |
| Hung, AM | 2 |
| Roumie, CL | 2 |
| Greevy, RA | 2 |
| Grijalva, CG | 2 |
| Murff, HJ | 2 |
| Griffin, MR | 2 |
| Halimi, S | 2 |
| Henry, RR | 2 |
| Logan, DK | 1 |
| Alessi, TR | 1 |
| Luskey, K | 1 |
| Baron, MA | 1 |
| Algariri, K | 1 |
| Meng, KY | 1 |
| Atangwho, IJ | 1 |
| Asmawi, MZ | 1 |
| Sadikun, A | 1 |
| Murugaiyah, V | 1 |
| Ismail, N | 1 |
| Marrero, D | 1 |
| Pan, Q | 3 |
| Barrett-Connor, E | 3 |
| de Groot, M | 1 |
| Zhang, P | 1 |
| Percy, C | 1 |
| Florez, H | 1 |
| Ackermann, R | 1 |
| Montez, M | 1 |
| Rubin, RR | 1 |
| Franzetti, IG | 4 |
| Querci, F | 4 |
| Carbone, A | 1 |
| Ciccarelli, L | 3 |
| Piccinni, MN | 3 |
| Chen, CH | 3 |
| Huang, MC | 3 |
| Kao, CF | 1 |
| Lin, SK | 2 |
| Kuo, PH | 1 |
| Chiu, CC | 3 |
| Lu, ML | 3 |
| Wu, D | 1 |
| Oh, TJ | 1 |
| Shin, JY | 1 |
| Kang, GH | 1 |
| Park, KS | 1 |
| Cho, YM | 1 |
| Salman, ZK | 1 |
| Refaat, R | 1 |
| Selima, E | 1 |
| El Sarha, A | 1 |
| Ismail, MA | 1 |
| Kovacs, CS | 2 |
| Seshiah, V | 2 |
| Swallow, R | 1 |
| Jones, R | 1 |
| Rattunde, H | 1 |
| Woerle, HJ | 7 |
| Broedl, UC | 6 |
| Du, Q | 1 |
| Wu, B | 1 |
| Wang, YJ | 1 |
| Yang, S | 1 |
| Zhao, YY | 1 |
| Liang, YY | 1 |
| Häring, HU | 5 |
| Merker, L | 4 |
| Seewaldt-Becker, E | 3 |
| Weimer, M | 2 |
| Meinicke, T | 3 |
| Wang, JS | 2 |
| Huang, CN | 1 |
| Hung, YJ | 2 |
| Kwok, CF | 1 |
| Sun, JH | 1 |
| Pei, D | 1 |
| Yang, CY | 1 |
| Chen, CC | 1 |
| Lin, CL | 1 |
| Sheu, WH | 2 |
| Adaramoye, OA | 1 |
| Lawal, SO | 1 |
| Lavalle-González, FJ | 3 |
| Januszewicz, A | 1 |
| Davidson, J | 1 |
| Tong, C | 2 |
| Qiu, R | 2 |
| Canovatchel, W | 4 |
| Meininger, G | 4 |
| Zenari, L | 1 |
| Marangoni, A | 2 |
| Kleefstra, N | 2 |
| Drion, I | 1 |
| van Hateren, KJ | 2 |
| Holleman, F | 1 |
| Goudswaard, AN | 1 |
| Bilo, HJ | 2 |
| Zhao, ZQ | 1 |
| Luo, R | 1 |
| Li, LY | 1 |
| Tian, FS | 1 |
| Zheng, XL | 1 |
| Xiong, HL | 1 |
| Sun, LT | 1 |
| Suhareva, OIu | 1 |
| Chernova, TO | 1 |
| Shmushkovich, IA | 1 |
| Aleksandrov, AA | 1 |
| Il'in, AV | 1 |
| Dedov, II | 1 |
| Checkley, LA | 1 |
| Rho, O | 1 |
| Angel, JM | 1 |
| Cho, J | 1 |
| Blando, J | 1 |
| Beltran, L | 1 |
| Hursting, SD | 2 |
| DiGiovanni, J | 1 |
| Lukashevich, V | 2 |
| Araga, M | 1 |
| Kothny, W | 2 |
| Moses, RG | 1 |
| Kalra, S | 1 |
| Brook, D | 1 |
| Sockler, J | 1 |
| Monyak, J | 1 |
| Visvanathan, J | 1 |
| Montanaro, M | 1 |
| Fisher, SA | 1 |
| Goring, S | 1 |
| Hawkins, N | 1 |
| Wygant, G | 1 |
| Roudaut, M | 1 |
| Townsend, R | 1 |
| Wood, I | 1 |
| Barnett, AH | 3 |
| Torekov, SS | 1 |
| Holst, JJ | 1 |
| Ehlers, MR | 1 |
| Miazgowski, T | 1 |
| Dziwura-Ogonowska, J | 1 |
| Safranow, K | 1 |
| Iskierska, K | 1 |
| Widecka, K | 1 |
| Seufert, J | 2 |
| Pegelow, K | 1 |
| Bramlage, P | 1 |
| Teslenko, IuV | 1 |
| Jensterle Sever, M | 1 |
| Kocjan, T | 2 |
| Pfeifer, M | 2 |
| Kravos, NA | 2 |
| Janez, A | 3 |
| Fiorentino, TV | 2 |
| Sesti, G | 1 |
| Nicolle, LE | 1 |
| Capuano, G | 1 |
| Fung, A | 4 |
| Usiskin, K | 2 |
| Pratley, RE | 2 |
| Fleck, P | 1 |
| Wilson, C | 1 |
| Fan, H | 1 |
| Forest, T | 1 |
| Holder, D | 1 |
| Smith, A | 1 |
| Cunningham, C | 1 |
| Yao, X | 1 |
| Dey, M | 1 |
| Frederick, C | 1 |
| Prahalada, S | 1 |
| Dziuba, J | 1 |
| Alperin, P | 1 |
| Racketa, J | 1 |
| Iloeje, U | 1 |
| Goswami, D | 1 |
| Perlstein, I | 1 |
| Grossman, HL | 1 |
| Cohen, M | 1 |
| Merovci, A | 1 |
| Solis-Herrera, C | 2 |
| Daniele, G | 1 |
| Eldor, R | 1 |
| Tripathy, D | 1 |
| Xiong, J | 1 |
| Perez, Z | 1 |
| Norton, L | 1 |
| Abdul-Ghani, MA | 1 |
| DeFronzo, RA | 4 |
| Schnell, O | 1 |
| Konda, VR | 1 |
| Desai, A | 1 |
| Darland, G | 1 |
| Grayson, N | 1 |
| Bland, JS | 1 |
| Mousavi, Z | 1 |
| Dourandish, L | 1 |
| Rokni, H | 1 |
| Sadeghi, R | 1 |
| Rasoul Zakavi, S | 1 |
| Velija-Asimi, Z | 1 |
| Izetbegovic, S | 1 |
| Karamehic, J | 1 |
| Coric, J | 1 |
| Panjeta, M | 1 |
| Macic-Dzankovic, A | 1 |
| Djelilovic-Vranic, J | 1 |
| Dizdarevic-Bostandzic, A | 1 |
| Jensterle, M | 2 |
| Goldberg, RB | 1 |
| Temprosa, MG | 1 |
| Mather, KJ | 1 |
| Orchard, TJ | 1 |
| Kitabchi, AE | 2 |
| Watson, KE | 2 |
| Mogensen, UM | 1 |
| Andersson, C | 1 |
| Fosbøl, EL | 1 |
| Schramm, TK | 1 |
| Vaag, A | 6 |
| Scheller, NM | 1 |
| Torp-Pedersen, C | 1 |
| Gislason, G | 1 |
| Køber, L | 1 |
| Heise, T | 3 |
| Morrow, L | 1 |
| Hompesch, M | 2 |
| Kapitza, C | 1 |
| Abt, M | 1 |
| Ramsauer, M | 1 |
| Magnone, MC | 1 |
| Fuerst-Recktenwald, S | 1 |
| Li, CJ | 1 |
| Yu, Q | 1 |
| Yu, P | 1 |
| Zhang, QM | 1 |
| Ding, M | 1 |
| Yu, DM | 1 |
| Umpierrez, G | 1 |
| Tofé Povedano, S | 1 |
| Pérez Manghi, F | 1 |
| Shurzinske, L | 1 |
| Pechtner, V | 1 |
| Ahrén, B | 4 |
| Johnson, SL | 1 |
| Stewart, M | 1 |
| Cirkel, DT | 1 |
| Yang, F | 1 |
| Perry, C | 1 |
| Feinglos, MN | 1 |
| Nauck, MA | 5 |
| Langkilde, AM | 2 |
| Kashiwagi, A | 1 |
| Kazuta, K | 1 |
| Goto, K | 1 |
| Yoshida, S | 1 |
| Ueyama, E | 1 |
| Utsuno, A | 1 |
| Sha, S | 1 |
| Polidori, D | 1 |
| Natarajan, J | 1 |
| Farrell, K | 1 |
| Wang, SS | 1 |
| Sica, D | 1 |
| Rothenberg, P | 1 |
| Plum-Mörschel, L | 1 |
| Calgaroto, NS | 1 |
| Thomé, GR | 1 |
| da Costa, P | 1 |
| Baldissareli, J | 1 |
| Hussein, FA | 1 |
| Schmatz, R | 1 |
| Rubin, MA | 1 |
| Signor, C | 1 |
| Ribeiro, DA | 1 |
| Carvalho, FB | 1 |
| de Oliveira, LS | 1 |
| Pereira, LB | 1 |
| Morsch, VM | 1 |
| Schetinger, MR | 1 |
| Tahrani, AA | 2 |
| Wessels, B | 1 |
| Ciapaite, J | 1 |
| van den Broek, NM | 1 |
| Nicolay, K | 1 |
| Prompers, JJ | 1 |
| Lennox, R | 1 |
| Porter, DW | 1 |
| Flatt, PR | 2 |
| Holscher, C | 1 |
| Irwin, N | 1 |
| Gault, VA | 1 |
| Diamant, M | 4 |
| Shaginian, R | 1 |
| Malone, JK | 1 |
| Cleall, S | 1 |
| Reaney, M | 1 |
| de Vries, D | 1 |
| Hoogwerf, BJ | 2 |
| MacConell, L | 3 |
| Wolffenbuttel, BH | 1 |
| Yuan, Y | 1 |
| Wu, J | 1 |
| Hu, P | 2 |
| Li, Z | 2 |
| Moser, C | 1 |
| Vickers, SP | 1 |
| Brammer, R | 1 |
| Cheetham, SC | 1 |
| Drewe, J | 1 |
| Ko, G | 1 |
| Ijäs, H | 1 |
| Vääräsmäki, M | 1 |
| Saarela, T | 1 |
| Keravuo, R | 1 |
| Raudaskoski, T | 1 |
| Tsai, CM | 1 |
| Kuo, HC | 1 |
| Hsu, CN | 1 |
| Huang, LT | 1 |
| Tain, YL | 1 |
| Xu, Z | 1 |
| Sun, L | 2 |
| Ji, J | 1 |
| Miao, J | 1 |
| Huang, S | 1 |
| Wang, T | 1 |
| Owens, DR | 2 |
| Traylor, L | 1 |
| Dain, MP | 3 |
| Landgraf, W | 1 |
| Schumm-Draeger, PM | 1 |
| Burgess, L | 1 |
| Korányi, L | 1 |
| Hruba, V | 1 |
| Hamer-Maansson, JE | 1 |
| de Bruin, TW | 1 |
| Leiter, LA | 1 |
| Yoon, KH | 1 |
| Arias, P | 1 |
| Langslet, G | 1 |
| Balis, DA | 1 |
| Millington, D | 1 |
| Vercruysse, F | 1 |
| Luong, DQ | 1 |
| Oster, R | 1 |
| Ashraf, AP | 1 |
| El-Sharkawy, AA | 1 |
| Abdelmotaleb, GS | 1 |
| Aly, MK | 1 |
| Kabel, AM | 1 |
| Wu, Z | 1 |
| Shen, S | 2 |
| Tan, D | 1 |
| Jiang, D | 1 |
| Bai, B | 1 |
| Sun, X | 1 |
| Fu, S | 1 |
| Kim, C | 1 |
| Randolph, JF | 1 |
| Golden, SH | 1 |
| Labrie, F | 1 |
| Kong, S | 1 |
| Nan, B | 1 |
| Bell, K | 2 |
| Parasuraman, S | 1 |
| Shah, M | 1 |
| Raju, A | 1 |
| Graham, J | 1 |
| Lamerato, L | 1 |
| D'Souza, A | 1 |
| Montilla, S | 1 |
| Marchesini, G | 2 |
| Sammarco, A | 1 |
| Trotta, MP | 1 |
| Siviero, PD | 1 |
| Tomino, C | 1 |
| Melchiorri, D | 1 |
| Pani, L | 1 |
| Mkrtumian, AM | 1 |
| Markova, TN | 1 |
| Kichigin, VA | 1 |
| Podachina, SV | 1 |
| Zhuchkova, SM | 1 |
| Peters, A | 2 |
| Russell-Jones, D | 2 |
| Furber, S | 2 |
| Donsmark, M | 1 |
| Han, J | 4 |
| Maggs, D | 1 |
| D'Alessio, D | 1 |
| de Pablos-Velasco, P | 1 |
| Candelas, C | 1 |
| Vincent, M | 1 |
| Pilorget, V | 2 |
| Yki-Järvinen, H | 3 |
| Garber, AJ | 5 |
| Bailey, CJ | 5 |
| Morales Villegas, EC | 1 |
| Tang, W | 1 |
| Ptaszynska, A | 3 |
| List, JF | 2 |
| Cook, W | 1 |
| Minervini, G | 1 |
| Bryzinski, B | 1 |
| Hirshberg, B | 1 |
| Flory, JH | 1 |
| Mushlin, AI | 1 |
| Anisimov, VN | 4 |
| Popovich, IG | 4 |
| Zabezhinski, MA | 4 |
| Egormin, PA | 4 |
| Yurova, MN | 2 |
| Semenchenko, AV | 4 |
| Tyndyk, ML | 4 |
| Panchenko, AV | 1 |
| Trashkov, AP | 1 |
| Vasiliev, AG | 1 |
| Khaitsev, NV | 1 |
| Song, YM | 1 |
| Kim, JW | 1 |
| Ham, DS | 1 |
| Kang, ES | 1 |
| Cha, BS | 2 |
| Lee, HC | 2 |
| Lee, BW | 1 |
| Portela, LV | 1 |
| Gnoatto, J | 1 |
| Brochier, AW | 1 |
| Haas, CB | 1 |
| de Assis, AM | 1 |
| de Carvalho, AK | 1 |
| Hansel, G | 1 |
| Zimmer, ER | 1 |
| Oses, JP | 1 |
| Muller, AP | 1 |
| Bode, B | 2 |
| Stenlöf, K | 2 |
| Harris, S | 1 |
| Sullivan, D | 1 |
| Genuth, S | 1 |
| Heinäniemi, M | 1 |
| Eerola, K | 1 |
| Ruohonen, ST | 1 |
| Cifarelli, V | 1 |
| Lashinger, LM | 1 |
| Devlin, KL | 1 |
| Dunlap, SM | 1 |
| Huang, J | 1 |
| Kaaks, R | 1 |
| Pollak, MN | 1 |
| Rosales, R | 1 |
| Abou Jaoude, E | 1 |
| Al-Arouj, M | 1 |
| Fawwad, A | 1 |
| Orabi, A | 1 |
| Shah, P | 1 |
| DiTommaso, S | 1 |
| Vaz, J | 1 |
| Latif, ZA | 1 |
| Matthaei, S | 3 |
| Bowering, K | 2 |
| Grohl, A | 1 |
| Lapolla, A | 1 |
| Frison, V | 1 |
| Bettio, M | 1 |
| Dal Pos, M | 1 |
| Rocchini, P | 1 |
| Panebianco, G | 1 |
| Tadiotto, F | 1 |
| Da Tos, V | 2 |
| D'Ambrosio, M | 1 |
| Ferrari, M | 1 |
| Pianta, A | 1 |
| Balzano, S | 1 |
| Confortin, L | 1 |
| Lamonica, M | 1 |
| Marin, N | 1 |
| Strazzabosco, M | 1 |
| Brun, E | 1 |
| Mesturino, CA | 1 |
| Simoncini, M | 1 |
| Zen, F | 1 |
| Bax, G | 1 |
| Bonsembiante, B | 1 |
| Cardone, C | 1 |
| Dal Frà, MG | 1 |
| Gallo, A | 1 |
| Masin, M | 1 |
| Piarulli, F | 1 |
| Sartore, G | 1 |
| Simioni, N | 1 |
| Maffei, L | 1 |
| Theuerkauf, A | 1 |
| Amin, NB | 1 |
| Jain, SM | 1 |
| Lee, DS | 1 |
| Nucci, G | 1 |
| Rusnak, JM | 1 |
| Al-Barazanji, K | 1 |
| McNulty, J | 1 |
| Binz, J | 1 |
| Generaux, C | 1 |
| Benson, W | 1 |
| Young, A | 1 |
| Abdelkader, D | 1 |
| Hassan, W | 1 |
| Sun, H | 1 |
| Chiefari, E | 1 |
| Capula, C | 1 |
| Vero, A | 1 |
| Oliverio, R | 1 |
| Puccio, L | 1 |
| Liguori, R | 1 |
| Pullano, V | 1 |
| Greco, M | 1 |
| Foti, D | 1 |
| Tirinato, D | 1 |
| Vero, R | 1 |
| Brunetti, A | 1 |
| Mearns, ES | 1 |
| Sobieraj, DM | 1 |
| White, CM | 1 |
| Saulsberry, WJ | 1 |
| Kohn, CG | 1 |
| Doleh, Y | 1 |
| Zaccaro, E | 1 |
| Coleman, CI | 2 |
| Thong, KY | 1 |
| Gupta, PS | 1 |
| Blann, AD | 1 |
| Ryder, RE | 1 |
| Probstfield, JL | 1 |
| Hirsch, I | 1 |
| O'Brien, K | 1 |
| Davis, B | 1 |
| Bergenstal, R | 1 |
| Kingry, C | 1 |
| Khakpour, D | 1 |
| Pressel, S | 1 |
| Branch, KR | 1 |
| Riddle, M | 1 |
| Lian, F | 1 |
| Tian, J | 1 |
| Piao, C | 1 |
| Zhao, L | 1 |
| Xia, C | 1 |
| Wang, CZ | 1 |
| Yuan, CS | 1 |
| Tong, X | 1 |
| Christiansen, AV | 2 |
| Roux, F | 2 |
| Salsali, A | 2 |
| Kim, G | 2 |
| Stella, P | 1 |
| Ikeda, S | 1 |
| Takano, Y | 1 |
| Cynshi, O | 1 |
| Tanaka, R | 1 |
| Christ, AD | 1 |
| Boerlin, V | 1 |
| Beyer, U | 1 |
| Beck, A | 1 |
| Ciorciaro, C | 1 |
| Meyer, M | 1 |
| Kadowaki, T | 1 |
| Ahmann, A | 1 |
| Rodbard, HW | 2 |
| Lahtela, JT | 1 |
| de Loredo, L | 1 |
| Tornøe, K | 1 |
| Boopalan, A | 1 |
| Sanduloviciu, M | 1 |
| Jornayvaz, FR | 2 |
| Okanović, A | 1 |
| Prnjavorac, B | 1 |
| Jusufović, E | 1 |
| Sejdinović, R | 1 |
| Kuznetsova, LA | 1 |
| Sharova, TS | 1 |
| Ignatieva, PA | 1 |
| Bondareva, VM | 1 |
| Hurliman, A | 1 |
| Keller Brown, J | 1 |
| Maille, N | 1 |
| Mandala, M | 1 |
| Casson, P | 1 |
| Osol, G | 1 |
| Haering, HU | 1 |
| Tanaka, K | 1 |
| Saisho, Y | 1 |
| Manesso, E | 1 |
| Tanaka, M | 1 |
| Meguro, S | 1 |
| Irie, J | 1 |
| Sugiura, H | 1 |
| Kawai, T | 1 |
| Jinzaki, M | 1 |
| Cobelli, C | 1 |
| Itoh, H | 1 |
| Kuzik, N | 1 |
| Myette-Côté, É | 1 |
| Carson, V | 1 |
| Slater, L | 1 |
| Boulé, NG | 1 |
| Pellonperä, O | 1 |
| Rönnemaa, T | 3 |
| Ekblad, U | 1 |
| Vahlberg, T | 1 |
| Tertti, K | 1 |
| Triplitt, C | 1 |
| Hinnen, D | 1 |
| Chang, F | 1 |
| O'Hare, AM | 1 |
| Miao, Y | 1 |
| Steinman, MA | 1 |
| de Silva, VA | 1 |
| Dayabandara, M | 1 |
| Wijesundara, H | 1 |
| Henegama, T | 1 |
| Gunewardena, H | 1 |
| Suraweera, C | 1 |
| Hanwella, R | 1 |
| Jo, W | 1 |
| Yu, ES | 1 |
| Chang, M | 1 |
| Park, HK | 1 |
| Choi, HJ | 1 |
| Ryu, JE | 1 |
| Jang, S | 1 |
| Lee, HJ | 1 |
| Jang, JJ | 1 |
| Son, WC | 1 |
| Mesbah, F | 1 |
| Moslem, M | 1 |
| Vojdani, Z | 1 |
| Mirkhani, H | 1 |
| Eliaschewitz, FG | 1 |
| Cerdas, S | 1 |
| Chacon, Mdel P | 1 |
| Alba, M | 3 |
| Han, P | 1 |
| Min, KW | 1 |
| Mansfield, T | 1 |
| T'Joen, C | 1 |
| Iqbal, N | 3 |
| Libman, IM | 1 |
| Miller, KM | 1 |
| DiMeglio, LA | 1 |
| Bethin, KE | 1 |
| Katz, ML | 1 |
| Shah, A | 1 |
| Simmons, JH | 1 |
| Haller, MJ | 1 |
| Raman, S | 1 |
| Tamborlane, WV | 1 |
| Coffey, JK | 1 |
| Saenz, AM | 1 |
| Beck, RW | 1 |
| Nadeau, KJ | 2 |
| Kim, HJ | 3 |
| Jin, BY | 1 |
| Oh, MJ | 1 |
| Shin, KH | 2 |
| Choi, SH | 2 |
| Kim, DH | 2 |
| Vaez, H | 1 |
| Rameshrad, M | 1 |
| Najafi, M | 1 |
| Barar, J | 1 |
| Barzegari, A | 1 |
| Garjani, A | 1 |
| Zhang, M | 1 |
| Tong, N | 1 |
| Mamza, J | 2 |
| Mehta, R | 2 |
| Donnelly, R | 2 |
| Idris, I | 2 |
| Wu, RR | 2 |
| Zhang, FY | 1 |
| Gao, KM | 1 |
| Ou, JJ | 2 |
| Shao, P | 2 |
| Jin, H | 2 |
| Guo, WB | 1 |
| Chan, PK | 2 |
| Zhao, JP | 2 |
| Tomczyk, R | 1 |
| Ociepka, A | 1 |
| Kiałka, M | 1 |
| Milewicz, T | 1 |
| Migacz, K | 1 |
| Kowalczuk, A | 1 |
| Klocek, M | 1 |
| Lundby-Christensen, L | 2 |
| Tarnow, L | 5 |
| Boesgaard, TW | 2 |
| Lund, SS | 6 |
| Wiinberg, N | 2 |
| Perrild, H | 2 |
| Krarup, T | 2 |
| Snorgaard, O | 2 |
| Gade-Rasmussen, B | 2 |
| Thorsteinsson, B | 2 |
| Røder, M | 2 |
| Mathiesen, ER | 2 |
| Jensen, T | 2 |
| Vestergaard, H | 2 |
| Hedetoft, C | 2 |
| Breum, L | 2 |
| Duun, E | 2 |
| Sneppen, SB | 2 |
| Pedersen, O | 4 |
| Hemmingsen, B | 2 |
| Carstensen, B | 2 |
| Madsbad, S | 2 |
| Gluud, C | 2 |
| Wetterslev, J | 2 |
| Almdal, TP | 2 |
| Ji, C | 1 |
| Jin, L | 1 |
| Blonde, L | 2 |
| Kim, EK | 1 |
| Lee, SH | 1 |
| Jhun, JY | 1 |
| Byun, JK | 1 |
| Jeong, JH | 1 |
| Lee, SY | 1 |
| Kim, JK | 1 |
| Choi, JY | 1 |
| Cho, ML | 1 |
| Zang, L | 1 |
| Geng, J | 1 |
| Bian, F | 1 |
| Lv, X | 1 |
| Yang, J | 3 |
| Bosch-Traberg, H | 2 |
| Mu, Y | 1 |
| Allas, S | 1 |
| Delale, T | 1 |
| Ngo, N | 1 |
| Julien, M | 1 |
| Sahakian, P | 1 |
| Ritter, J | 1 |
| Abribat, T | 1 |
| van der Lely, AJ | 1 |
| Hodge, RJ | 1 |
| Paulik, MA | 1 |
| Walker, A | 1 |
| Boucheron, JA | 1 |
| McMullen, SL | 1 |
| Gillmor, DS | 1 |
| Nunez, DJ | 1 |
| Mukherjee, J | 1 |
| Sternhufvud, C | 1 |
| Smith, N | 1 |
| Stott-Miller, M | 1 |
| McMorrow, D | 1 |
| Johnston, S | 1 |
| Firouzjaei, A | 1 |
| Li, GC | 1 |
| Wang, N | 1 |
| Liu, WX | 1 |
| Zhu, BM | 1 |
| Birch Petersen, K | 1 |
| Pedersen, NG | 1 |
| Pedersen, AT | 1 |
| Lauritsen, MP | 1 |
| la Cour Freiesleben, N | 1 |
| Aggarwal, N | 2 |
| Cao, A | 1 |
| Marcus, MD | 1 |
| Wilfley, DE | 1 |
| El Ghormli, L | 1 |
| Zeitler, P | 1 |
| Linder, B | 1 |
| Hirst, K | 1 |
| Ievers-Landis, CE | 1 |
| van Buren, DJ | 1 |
| Walders-Abramson, N | 1 |
| Guerci, B | 1 |
| Hanefeld, M | 2 |
| Gentile, S | 1 |
| Tinahones, FJ | 2 |
| Roy-Duval, C | 1 |
| Souhami, E | 2 |
| Wardecki, M | 1 |
| Perfetti, R | 2 |
| Heller, S | 1 |
| Kim, SS | 1 |
| Kim, IJ | 1 |
| Lee, KJ | 1 |
| Park, JH | 1 |
| Kim, YI | 1 |
| Lee, YS | 1 |
| Chung, SC | 1 |
| Lee, SJ | 1 |
| Wright, JJ | 1 |
| Tylee, TS | 1 |
| Jiang, P | 1 |
| Dong, Z | 1 |
| Ma, B | 1 |
| Ni, Z | 1 |
| Duan, H | 1 |
| Wei, Q | 1 |
| Ji, X | 1 |
| Schrijnders, D | 1 |
| Wever, R | 1 |
| Houweling, ST | 1 |
| de Bock, GH | 1 |
| Groenier, KH | 1 |
| Landman, GW | 1 |
| Silvestre, L | 1 |
| Zhou, T | 1 |
| Fonseca, V | 4 |
| Siskind, DJ | 1 |
| Leung, J | 1 |
| Russell, AW | 1 |
| Wysoczanski, D | 1 |
| Rizzo, M | 1 |
| Johnson, A | 1 |
| Madsen, J | 1 |
| Okamoto, A | 1 |
| Yokokawa, H | 1 |
| Sanada, H | 1 |
| Naito, T | 1 |
| Bailey, TS | 1 |
| Takács, R | 1 |
| Rao, PV | 1 |
| Tsoukas, GM | 1 |
| Thomsen, AB | 2 |
| Maislos, M | 1 |
| Herrera Marmolejo, M | 1 |
| González González, JG | 1 |
| Hansen, L | 2 |
| Schernthaner, G | 3 |
| Davidson, JA | 3 |
| Jodon, H | 1 |
| Vijapurkar, U | 1 |
| Lu, CH | 1 |
| Hsieh, PS | 1 |
| Garcia-Hernandez, P | 1 |
| Chin, A | 1 |
| Sam, WJ | 1 |
| Roza, O | 1 |
| Hon, YY | 1 |
| Alfaro, RM | 1 |
| Calis, KA | 2 |
| Reynolds, JC | 2 |
| Yanovski, JA | 2 |
| Martinez, JA | 1 |
| Chalasani, P | 1 |
| Thomson, CA | 1 |
| Roe, D | 1 |
| Altbach, M | 1 |
| Galons, JP | 1 |
| Stopeck, A | 1 |
| Thompson, PA | 1 |
| Villa-Guillen, DE | 1 |
| Chow, HH | 1 |
| Wójcicka, G | 1 |
| Jamroz-Wiśniewska, A | 1 |
| Czechowska, G | 1 |
| Korolczuk, A | 1 |
| Marciniak, S | 1 |
| Bełtowski, J | 1 |
| Li, R | 2 |
| Chen, LZ | 1 |
| Zhao, W | 1 |
| Zhao, SP | 1 |
| Huang, XS | 1 |
| Rath, D | 1 |
| Kar, DM | 1 |
| Panigrahi, SK | 1 |
| Maharana, L | 1 |
| Jordan, J | 1 |
| Wanner, C | 1 |
| Heer, M | 1 |
| Macha, S | 1 |
| Mattheus, M | 1 |
| Huang, YS | 1 |
| Li, YC | 1 |
| Tsai, PY | 1 |
| Lin, CE | 1 |
| Chen, CM | 1 |
| Chen, SM | 1 |
| Lee, JA | 1 |
| Broglio, F | 1 |
| Mannucci, E | 1 |
| Napoli, R | 1 |
| Purrello, F | 1 |
| Nikonova, E | 1 |
| Stager, W | 1 |
| Trevisan, R | 1 |
| de Lapertosa, SB | 1 |
| Frechtel, G | 1 |
| Sauque-Reyna, L | 1 |
| Mostafa, DK | 1 |
| Nasra, RA | 1 |
| Zahran, N | 1 |
| Ghoneim, MT | 1 |
| de Oliveira Santana, KN | 1 |
| Lelis, DF | 1 |
| Mendes, KL | 1 |
| Lula, JF | 1 |
| Paraíso, AF | 1 |
| Andrade, JM | 1 |
| Feltenberger, JD | 1 |
| Cota, J | 1 |
| da Costa, DV | 1 |
| de Paula, AM | 1 |
| Guimarães, AL | 1 |
| Santos, SH | 1 |
| Zou, P | 1 |
| Zhou, M | 1 |
| Shree, N | 1 |
| Bhonde, RR | 1 |
| Sloan, L | 1 |
| Dawed, A | 1 |
| Heggie, A | 1 |
| Jones, AG | 1 |
| Dekker, J | 1 |
| Koivula, R | 1 |
| Hansen, TH | 1 |
| Stewart, C | 1 |
| Holman, RR | 1 |
| Franks, PW | 2 |
| Walker, M | 1 |
| Pearson, ER | 1 |
| Iglesias, DA | 1 |
| Celestino, J | 1 |
| Sun, CC | 1 |
| Yates, MS | 1 |
| Schmandt, RE | 1 |
| Lu, KH | 1 |
| Petrie, JR | 1 |
| Chaturvedi, N | 1 |
| Ford, I | 1 |
| Hramiak, I | 1 |
| Hughes, AD | 1 |
| Jenkins, AJ | 1 |
| E Klein, B | 1 |
| Klein, R | 1 |
| Ooi, TC | 1 |
| Rossing, P | 2 |
| Stehouwer, CD | 3 |
| Colhoun, HM | 1 |
| Chen, PY | 1 |
| Lin, YK | 1 |
| Goričar, K | 1 |
| Wu, R | 1 |
| Metais, C | 1 |
| Forcheron, F | 3 |
| Abdallah, P | 2 |
| Basset, A | 3 |
| Del Carmine, P | 3 |
| Bricca, G | 1 |
| Beylot, M | 3 |
| Atabek, ME | 1 |
| Pirgon, O | 1 |
| Romualdi, D | 1 |
| Costantini, B | 1 |
| Selvaggi, L | 1 |
| Giuliani, M | 1 |
| Cristello, F | 1 |
| Macrì, F | 1 |
| Bompiani, A | 1 |
| Lanzone, A | 1 |
| Guido, M | 1 |
| Kapoor, S | 1 |
| Correia, S | 1 |
| Carvalho, C | 1 |
| Santos, MS | 1 |
| Proença, T | 1 |
| Nunes, E | 2 |
| Duarte, AI | 1 |
| Monteiro, P | 2 |
| Seiça, R | 2 |
| Oliveira, CR | 1 |
| Moreira, PI | 1 |
| Lian, B | 1 |
| Cui, F | 1 |
| Shore, SA | 1 |
| Williams, ES | 1 |
| Zhu, M | 1 |
| Ehlers, LB | 1 |
| Zeitler, PS | 1 |
| Love-Osborne, K | 1 |
| Berstein, LM | 4 |
| Piskunova, TS | 3 |
| Yurova, MV | 2 |
| Kovalenko, IG | 3 |
| Poroshina, TE | 3 |
| Schweizer, A | 2 |
| Minic, B | 2 |
| Foley, J | 2 |
| Dejager, S | 4 |
| Astrup, AS | 1 |
| Hovind, P | 1 |
| Jacobsen, PK | 1 |
| Alibegovic, AC | 1 |
| Parving, I | 1 |
| Pietraszek, L | 1 |
| Frandsen, M | 3 |
| Parving, HH | 3 |
| Vaag, AA | 2 |
| Luque-Ramírez, M | 1 |
| Alvarez-Blasco, F | 1 |
| Escobar-Morreale, HF | 1 |
| Meddah, B | 1 |
| Ducroc, R | 1 |
| El Abbes Faouzi, M | 1 |
| Eto, B | 1 |
| Mahraoui, L | 1 |
| Benhaddou-Andaloussi, A | 1 |
| Martineau, LC | 1 |
| Cherrah, Y | 1 |
| Haddad, PS | 1 |
| Ascić-Buturović, B | 1 |
| Kacila, M | 1 |
| Matthews, D | 1 |
| Byiers, S | 1 |
| Shao, Q | 2 |
| Raso, GM | 1 |
| Esposito, E | 1 |
| Iacono, A | 1 |
| Pacilio, M | 1 |
| Cuzzocrea, S | 1 |
| Canani, RB | 1 |
| Calignano, A | 1 |
| Meli, R | 1 |
| Adeneye, AA | 1 |
| Amole, OO | 1 |
| Agbaje, EO | 1 |
| Izegbu, MC | 1 |
| Elias, SO | 1 |
| Tamrakar, AK | 1 |
| Piya, MK | 1 |
| Bosi, E | 2 |
| Carracedo-Martínez, E | 1 |
| Pia-Morandeira, A | 1 |
| Home, PD | 1 |
| Pocock, SJ | 1 |
| Beck-Nielsen, H | 4 |
| Curtis, PS | 1 |
| Gomis, R | 1 |
| Jones, NP | 1 |
| Komajda, M | 1 |
| McMurray, JJ | 1 |
| Bolli, G | 2 |
| Dotta, F | 2 |
| Colin, L | 1 |
| Goodman, M | 1 |
| Carrizo, E | 2 |
| Fernández, V | 2 |
| Connell, L | 2 |
| Sandia, I | 1 |
| Prieto, D | 1 |
| Mogollón, J | 1 |
| Valbuena, D | 1 |
| Fernández, I | 1 |
| de Baptista, EA | 2 |
| Baptista, T | 2 |
| Mitri, J | 1 |
| Hamdy, O | 1 |
| Haffar, G | 1 |
| Brill, DS | 1 |
| Moenter, SM | 1 |
| Kiyici, S | 1 |
| Ersoy, C | 1 |
| Oz Gul, O | 1 |
| Sarandol, E | 1 |
| Demirci, M | 1 |
| Tuncel, E | 1 |
| Sigirli, D | 1 |
| Erturk, E | 1 |
| Imamoglu, S | 1 |
| Hartemann-Heurtier, A | 1 |
| Halbron, M | 1 |
| Golmard, JL | 1 |
| Jacqueminet, S | 1 |
| Bastard, JP | 1 |
| Rouault, C | 1 |
| Ayed, A | 1 |
| Pieroni, L | 1 |
| Clément, K | 1 |
| Grimaldi, A | 1 |
| Schmitz, O | 1 |
| Sethi, BK | 1 |
| Lalic, N | 1 |
| Antic, S | 1 |
| Zdravkovic, M | 2 |
| Ravn, GM | 1 |
| Simó, R | 1 |
| Balani, J | 1 |
| Hyer, SL | 1 |
| Rodin, DA | 1 |
| Shehata, H | 1 |
| Tinelli, C | 1 |
| Gross, JL | 1 |
| Nakano, M | 1 |
| Colon-Vega, G | 1 |
| Ortiz-Carasquillo, R | 1 |
| Ferguson, JA | 1 |
| Althouse, S | 1 |
| Tobian, JA | 1 |
| Berclaz, PY | 1 |
| Diaz, M | 1 |
| Marcos, MV | 1 |
| Wang, Z | 1 |
| Riethoven, JJ | 1 |
| Xia, Y | 1 |
| Miner, J | 1 |
| Fromm, M | 1 |
| Bushe, CJ | 1 |
| Bradley, AJ | 1 |
| Doshi, S | 1 |
| Karagianis, J | 1 |
| Quaile, MP | 1 |
| Melich, DH | 1 |
| Jordan, HL | 1 |
| Nold, JB | 1 |
| Chism, JP | 1 |
| Polli, JW | 1 |
| Smith, GA | 1 |
| Rhodes, MC | 1 |
| Salvadeo, SA | 2 |
| Ferrari, I | 2 |
| Ragonesi, PD | 2 |
| Gadaleta, G | 2 |
| Cicero, AF | 2 |
| Waters, SB | 1 |
| Topp, BG | 1 |
| Siler, SQ | 1 |
| Alexander, CM | 2 |
| Hwang, IK | 2 |
| Kim, IY | 1 |
| Joo, EJ | 1 |
| Shin, JH | 1 |
| Choi, JW | 1 |
| Won, MH | 2 |
| Yoon, YS | 2 |
| Seong, JK | 1 |
| Yan, L | 1 |
| Kang, B | 1 |
| Yin, Z | 1 |
| Kanazawa, I | 1 |
| Yamaguchi, T | 1 |
| Yano, S | 1 |
| Yamamoto, M | 1 |
| Yamauchi, M | 1 |
| Kurioka, S | 1 |
| Sugimoto, T | 1 |
| Lim, SS | 1 |
| Norman, RJ | 4 |
| Noakes, M | 2 |
| Aubert, G | 1 |
| Mansuy, V | 1 |
| Voirol, MJ | 1 |
| Pellerin, L | 1 |
| Pralong, FP | 1 |
| Smith, DL | 1 |
| Elam, CF | 1 |
| Mattison, JA | 1 |
| Lane, MA | 1 |
| Roth, GS | 1 |
| Ingram, DK | 1 |
| Allison, DB | 1 |
| Zanchi, A | 1 |
| Maillard, M | 1 |
| Vinciguerra, M | 1 |
| Deleaval, P | 1 |
| Nussberger, J | 1 |
| Burnier, M | 1 |
| Pechere-Bertschi, A | 1 |
| McEwan, P | 1 |
| Evans, M | 1 |
| Kan, H | 1 |
| Bergenheim, K | 1 |
| Ehret, M | 1 |
| Goethe, J | 1 |
| Lanosa, M | 1 |
| Matsui, Y | 1 |
| Hirasawa, Y | 1 |
| Sugiura, T | 1 |
| Toyoshi, T | 1 |
| Kyuki, K | 1 |
| Ito, M | 1 |
| Aghahosseini, M | 1 |
| Aleyaseen, A | 1 |
| Safdarian, L | 1 |
| Moddaress-Hashemi, S | 1 |
| Mofid, B | 1 |
| Kashani, L | 1 |
| Gray, SL | 1 |
| Donald, C | 1 |
| Jetha, A | 1 |
| Covey, SD | 1 |
| Kieffer, TJ | 1 |
| Wiegand, S | 1 |
| l'Allemand, D | 1 |
| Hübel, H | 1 |
| Krude, H | 1 |
| Bürmann, M | 1 |
| Martus, P | 1 |
| Grüters, A | 1 |
| Holl, RW | 1 |
| Matthews, DR | 3 |
| Couturier, A | 1 |
| Foley, JE | 1 |
| Lee, HH | 1 |
| Yeh, CH | 1 |
| Chen, YT | 1 |
| Chi, TC | 1 |
| Cheng, JT | 1 |
| Lo, SH | 1 |
| Oldham, J | 1 |
| Khan, AY | 1 |
| Macaluso, M | 1 |
| McHale, RJ | 1 |
| Dahmen, MM | 1 |
| Girrens, K | 1 |
| Ali, F | 1 |
| Huizinga, MM | 1 |
| Schmidt, WE | 1 |
| Durán, A | 1 |
| Martín, P | 1 |
| Runkle, I | 1 |
| Pérez, N | 1 |
| Abad, R | 1 |
| Fernández, M | 1 |
| Del Valle, L | 1 |
| Sanz, MF | 1 |
| Calle-Pascual, AL | 2 |
| Gram, J | 2 |
| Henriksen, JE | 1 |
| Grodum, E | 1 |
| Juhl, H | 1 |
| Hansen, TB | 1 |
| Christiansen, C | 1 |
| Yderstræde, K | 1 |
| Gjessing, H | 1 |
| Hansen, HM | 1 |
| Vestergaard, V | 1 |
| Hangaard, J | 1 |
| Qiang, GF | 1 |
| Xuan, Q | 1 |
| Yang, XY | 1 |
| Shi, LL | 1 |
| Zhang, HA | 1 |
| Chen, BN | 1 |
| Du, GH | 1 |
| Holloway, AC | 1 |
| Hettinga, BP | 1 |
| Jansen, HJ | 1 |
| Vervoort, G | 1 |
| van der Graaf, M | 1 |
| Bergenstal, RM | 1 |
| Glass, LC | 1 |
| Heilmann, CR | 1 |
| Lewis, MS | 1 |
| Kwan, AY | 1 |
| Rosenfeld, SV | 1 |
| Louro, TM | 1 |
| Matafome, PN | 1 |
| Nunes, EC | 1 |
| da Cunha, FX | 1 |
| Seiça, RM | 1 |
| Matafome, P | 1 |
| Louro, T | 1 |
| Rodrigues, L | 1 |
| Crisóstomo, J | 1 |
| Amaral, C | 1 |
| Cipriano, A | 1 |
| Krakoff, J | 1 |
| Salaita, CG | 1 |
| McDuffie, JR | 1 |
| Kozlosky, M | 1 |
| Sebring, NG | 1 |
| Brady, SM | 1 |
| Bhutada, P | 1 |
| Mundhada, Y | 1 |
| Bansod, K | 1 |
| Tawari, S | 1 |
| Patil, S | 1 |
| Dixit, P | 1 |
| Umathe, S | 1 |
| Mundhada, D | 1 |
| Benes, J | 1 |
| Kazdova, L | 1 |
| Drahota, Z | 1 |
| Houstek, J | 1 |
| Medrikova, D | 1 |
| Kopecky, J | 1 |
| Kovarova, N | 1 |
| Vrbacky, M | 1 |
| Sedmera, D | 1 |
| Strnad, H | 1 |
| Kolar, M | 1 |
| Petrak, J | 1 |
| Benada, O | 1 |
| Skaroupkova, P | 1 |
| Cervenka, L | 1 |
| Melenovsky, V | 1 |
| Reviriego, J | 1 |
| Karamanos, V | 1 |
| del Cañizo, FJ | 1 |
| Vlachogiannis, N | 1 |
| Drossinos, V | 1 |
| Liepinsh, E | 1 |
| Skapare, E | 1 |
| Svalbe, B | 1 |
| Makrecka, M | 1 |
| Cirule, H | 1 |
| Dambrova, M | 1 |
| Freeman, JS | 1 |
| Erejuwa, OO | 1 |
| Sulaiman, SA | 1 |
| Wahab, MS | 1 |
| Sirajudeen, KN | 1 |
| Salleh, MS | 1 |
| Gurtu, S | 1 |
| Ghatak, SB | 1 |
| Dhamecha, PS | 1 |
| Bhadada, SV | 1 |
| Panchal, SJ | 1 |
| Ghandi, S | 1 |
| Aflatoonian, A | 1 |
| Tabibnejad, N | 1 |
| Moghaddam, MH | 1 |
| Putignano, P | 1 |
| Bossi, AC | 1 |
| Bonaventura, A | 1 |
| Guazzini, B | 1 |
| Testori, G | 1 |
| Sathyanarayana, P | 2 |
| Jogi, M | 2 |
| Muthupillai, R | 2 |
| Krishnamurthy, R | 2 |
| Samson, SL | 2 |
| Bajaj, M | 2 |
| Kravchuk, E | 1 |
| Grineva, E | 1 |
| Bairamov, A | 1 |
| Yoo, DY | 1 |
| Kim, W | 1 |
| Nam, SM | 1 |
| Yoo, KY | 1 |
| Lee, CH | 1 |
| Choi, JH | 1 |
| Bunck, MC | 1 |
| Cornér, A | 1 |
| Eliasson, B | 1 |
| Heine, RJ | 1 |
| Shaginian, RM | 1 |
| Taskinen, MR | 3 |
| Smith, U | 2 |
| Meneghini, LF | 2 |
| Orozco-Beltran, D | 1 |
| Caputo, S | 1 |
| Damçi, T | 2 |
| Liebl, A | 1 |
| Ross, SA | 2 |
| Kaneb, HM | 1 |
| Sharp, PS | 1 |
| Rahmani-Kondori, N | 1 |
| Wells, DJ | 1 |
| Vasconcelos, CF | 1 |
| Maranhão, HM | 1 |
| Batista, TM | 1 |
| Carneiro, EM | 1 |
| Ferreira, F | 1 |
| Costa, J | 1 |
| Soares, LA | 1 |
| Sá, MD | 1 |
| Souza, TP | 1 |
| Wanderley, AG | 1 |
| Lee, CG | 1 |
| Boyko, EJ | 1 |
| Miljkovic, I | 1 |
| Hoffman, AR | 1 |
| Everson-Rose, SA | 1 |
| Lewis, CE | 1 |
| Cawthon, PM | 1 |
| Strotmeyer, ES | 1 |
| Orwoll, ES | 1 |
| Gonzalez, EV | 1 |
| Gutierrez, A | 1 |
| Chan, L | 1 |
| Chen, WL | 1 |
| Wei, HW | 1 |
| Chiu, WZ | 1 |
| Kang, CH | 1 |
| Lin, TH | 1 |
| Hung, CC | 1 |
| Chen, MC | 1 |
| Shieh, MS | 1 |
| Lee, CC | 1 |
| Lee, HM | 1 |
| McIntosh, B | 1 |
| Cameron, C | 1 |
| Singh, SR | 1 |
| Yu, C | 1 |
| Ahuja, T | 1 |
| Welton, NJ | 1 |
| Dahl, M | 1 |
| Lin, SD | 1 |
| Lee, WJ | 1 |
| Su, SL | 1 |
| Lee, IT | 1 |
| Tu, ST | 1 |
| Tseng, YH | 1 |
| Lin, SY | 1 |
| Bray, GA | 1 |
| Ryan, DH | 1 |
| Lobato, NS | 1 |
| Filgueira, FP | 1 |
| Hagihara, GN | 1 |
| Pariz, JR | 1 |
| Tostes, RC | 1 |
| Carvalho, MH | 2 |
| Fortes, ZB | 2 |
| Qiu, LL | 1 |
| Mou, YR | 1 |
| Zhao, JJ | 1 |
| Dong, JJ | 1 |
| Delahanty, LM | 1 |
| Jablonski, KA | 1 |
| McCaffery, JM | 1 |
| Shuldiner, A | 1 |
| Kahn, SE | 2 |
| Knowler, WC | 2 |
| Florez, JC | 1 |
| Bolinder, J | 1 |
| Ljunggren, Ö | 1 |
| Kullberg, J | 1 |
| Johansson, L | 1 |
| Bardin, C | 1 |
| Nobecourt, E | 1 |
| Larger, E | 1 |
| Chast, F | 1 |
| Treluyer, JM | 1 |
| Urien, S | 1 |
| Yuan, J | 1 |
| Gao, B | 1 |
| Fu, G | 1 |
| Tu, Y | 1 |
| Auricchio, N | 1 |
| Malinowska, I | 1 |
| Shaw, R | 1 |
| Manning, BD | 1 |
| Kwiatkowski, DJ | 1 |
| Tong, JH | 1 |
| Zhu, G | 1 |
| Liang, GM | 1 |
| Yan, HF | 1 |
| Wang, XZ | 1 |
| Karagiannis, T | 1 |
| Paschos, P | 1 |
| Paletas, K | 1 |
| Tsapas, A | 1 |
| Murray, AV | 1 |
| Marmolejo, MH | 1 |
| Hennicken, D | 1 |
| Best, JD | 1 |
| Drury, PL | 1 |
| Davis, TM | 1 |
| Kesäniemi, YA | 1 |
| Scott, R | 2 |
| Pardy, C | 1 |
| Voysey, M | 1 |
| Keech, AC | 1 |
| Pei, L | 1 |
| Du, J | 1 |
| Ao, N | 1 |
| Liu, SC | 1 |
| Tu, YK | 1 |
| Chien, MN | 1 |
| Chien, KL | 1 |
| Iványi, T | 1 |
| Fövényi, J | 1 |
| Faludi, P | 1 |
| Wille, S | 1 |
| Kiljanski, J | 1 |
| Apaijai, N | 1 |
| Pintana, H | 1 |
| Chattipakorn, SC | 1 |
| Chattipakorn, N | 1 |
| Bagul, PK | 1 |
| Middela, H | 1 |
| Matapally, S | 1 |
| Padiya, R | 1 |
| Bastia, T | 1 |
| Madhusudana, K | 1 |
| Reddy, BR | 1 |
| Chakravarty, S | 1 |
| Banerjee, SK | 1 |
| Aschner, P | 1 |
| Chan, J | 1 |
| Picard, S | 1 |
| Wang, E | 1 |
| Echtay, A | 1 |
| Gao, K | 1 |
| Twamley, EW | 1 |
| Wang, J | 1 |
| Guo, XF | 1 |
| Davis, JM | 1 |
| Srivastava, S | 1 |
| Saxena, GN | 1 |
| Keshwani, P | 1 |
| Gupta, R | 1 |
| George, P | 1 |
| McCrimmon, RJ | 1 |
| Bailey, T | 1 |
| Montanya, E | 1 |
| Filetti, S | 1 |
| Davies, M | 1 |
| McNeilly, AD | 1 |
| Williamson, R | 1 |
| Balfour, DJ | 1 |
| Stewart, CA | 1 |
| Sutherland, C | 1 |
| Vora, J | 1 |
| Bain, SC | 1 |
| Dzida, G | 1 |
| Kozlovski, P | 1 |
| Lavrenko, AV | 1 |
| Shlykova, OA | 1 |
| Kutsenko, LA | 1 |
| Mamontova, TV | 1 |
| Kaĭdashev, IP | 1 |
| Sharma, AK | 1 |
| Raikwar, SK | 1 |
| Kurmi, MK | 1 |
| Srinivasan, BP | 1 |
| Leiria, LO | 1 |
| Sollon, C | 1 |
| Calixto, MC | 1 |
| Lintomen, L | 1 |
| Mónica, FZ | 1 |
| Anhê, GF | 1 |
| De Nucci, G | 1 |
| Zanesco, A | 1 |
| Grant, AD | 1 |
| Antunes, E | 1 |
| Taslimi, S | 1 |
| Esteghamati, A | 1 |
| Rashidi, A | 1 |
| Tavakkoli, HM | 1 |
| Nakhjavani, M | 1 |
| Kebriaee-Zadeh, A | 1 |
| Komazawa, H | 1 |
| Yamaguchi, H | 1 |
| Hidaka, K | 1 |
| Ogura, J | 1 |
| Kobayashi, M | 1 |
| Iseki, K | 1 |
| Massollo, M | 1 |
| Marini, C | 1 |
| Brignone, M | 1 |
| Emionite, L | 1 |
| Salani, B | 1 |
| Riondato, M | 1 |
| Capitanio, S | 1 |
| Fiz, F | 1 |
| Democrito, A | 1 |
| Amaro, A | 1 |
| Morbelli, S | 1 |
| Piana, M | 1 |
| Maggi, D | 1 |
| Cilli, M | 1 |
| Pfeffer, U | 1 |
| Sambuceti, G | 1 |
| Yang, JK | 1 |
| Zhang, XH | 1 |
| Park, EY | 1 |
| Chun, BG | 1 |
| Seman, L | 1 |
| Hantel, S | 1 |
| Pinnetti, S | 1 |
| Pan, C | 1 |
| Gao, Y | 1 |
| Gao, X | 1 |
| Luo, B | 1 |
| Shi, H | 1 |
| Tian, H | 1 |
| Jia, P | 1 |
| Lin, H | 1 |
| Xing, X | 1 |
| Marre, M | 2 |
| Howlett, H | 1 |
| Lehert, P | 1 |
| Allavoine, T | 1 |
| Kelly, CJ | 1 |
| Gordon, D | 1 |
| Bruce, S | 3 |
| Fiedorek, FT | 1 |
| Tankova, T | 1 |
| Koev, D | 1 |
| Dakovska, L | 1 |
| Kirilov, G | 1 |
| Hale, TW | 1 |
| Kristensen, JH | 1 |
| Hackett, LP | 1 |
| Kohan, R | 1 |
| Ilett, KF | 1 |
| Hällsten, K | 2 |
| Virtanen, KA | 2 |
| Lönnqvist, F | 2 |
| Sipilä, H | 1 |
| Oksanen, A | 1 |
| Viljanen, T | 2 |
| Viikari, J | 1 |
| Knuuti, J | 2 |
| Nuutila, P | 2 |
| McNulty, SJ | 1 |
| Ur, E | 1 |
| Williams, G | 1 |
| Cleasby, ME | 1 |
| Livingstone, DE | 1 |
| Nyirenda, MJ | 1 |
| Seckl, JR | 1 |
| Walker, BR | 1 |
| Parkkola, R | 1 |
| Janatuinen, T | 1 |
| Huupponen, R | 4 |
| Lönnroth, P | 1 |
| Ashwell, CM | 1 |
| McMurtry, JP | 1 |
| Das, S | 1 |
| Valabhji, J | 1 |
| Watson, M | 1 |
| Cox, J | 1 |
| Poulter, C | 1 |
| Elwig, C | 1 |
| Elkeles, RS | 2 |
| Drzewoski, J | 1 |
| Czupryniak, L | 1 |
| Tuomilehto, J | 1 |
| Fineman, MS | 3 |
| Bicsak, TA | 1 |
| Shen, LZ | 1 |
| Taylor, K | 1 |
| Gaines, E | 1 |
| Varns, A | 1 |
| Kim, D | 1 |
| Baron, AD | 3 |
| Donovan, DS | 1 |
| Dandona, P | 1 |
| Park, JS | 1 |
| Schatz, H | 1 |
| Schoppel, K | 1 |
| Lehwalder, D | 1 |
| Schandry, R | 1 |
| Lord, JM | 1 |
| Flight, IH | 1 |
| Baillargeon, JP | 1 |
| Iuorno, MJ | 1 |
| Jakubowicz, DJ | 1 |
| Apridonidze, T | 1 |
| He, N | 1 |
| Nestler, JE | 1 |
| Abbasi, F | 1 |
| Chu, JW | 1 |
| McLaughlin, T | 1 |
| Lamendola, C | 1 |
| Leary, ET | 1 |
| Reaven, GM | 2 |
| Maciel, GA | 2 |
| Soares Júnior, JM | 1 |
| Alves da Motta, EL | 1 |
| de Lima, GR | 1 |
| Baracat, EC | 2 |
| Herrmann, BL | 1 |
| Berg, C | 1 |
| Vogel, E | 1 |
| Nowak, T | 1 |
| Renzing-Koehler, K | 1 |
| Mann, K | 3 |
| Saller, B | 1 |
| Glueck, CJ | 7 |
| Goldenberg, N | 4 |
| Wang, P | 7 |
| Loftspring, M | 2 |
| Sherman, A | 1 |
| Maggs, DG | 1 |
| Ruggles, JA | 1 |
| Fineman, M | 1 |
| Kolterman, OG | 1 |
| Weyer, C | 1 |
| Lebovitz, HE | 1 |
| Banerji, MA | 1 |
| Pranikoff, J | 3 |
| Sieve, L | 2 |
| Strowig, SM | 1 |
| Avilés-Santa, ML | 1 |
| Raskin, P | 3 |
| Bornovali, S | 1 |
| Dharashivkar, S | 1 |
| Rodríguez, Y | 1 |
| Giri, M | 1 |
| Feyen, E | 1 |
| Christophe, AB | 1 |
| Lord, J | 1 |
| Wilkin, T | 1 |
| Jayagopal, V | 1 |
| Kilpatrick, ES | 1 |
| Holding, S | 1 |
| Jennings, PE | 1 |
| Ashokkumar, N | 1 |
| Pari, L | 1 |
| Howlett, HC | 3 |
| Kilicdag, EB | 2 |
| Bagis, T | 2 |
| Zeyneloglu, HB | 1 |
| Tarim, E | 2 |
| Aslan, E | 2 |
| Haydardedeoglu, B | 2 |
| Erkanli, S | 2 |
| Santana, LF | 1 |
| de Sá, MF | 1 |
| Ferriani, RA | 1 |
| de Moura, MD | 1 |
| Foss, MC | 1 |
| dos Reis, RM | 1 |
| Lacigová, S | 1 |
| Rusavý, Z | 1 |
| Kyselová, P | 1 |
| Jankovec, Z | 1 |
| Kárová, R | 1 |
| Cechurová, D | 1 |
| Allen, E | 1 |
| Lewin, A | 1 |
| Gabbay, RA | 1 |
| Garber, A | 2 |
| Ceriello, A | 1 |
| Johns, D | 2 |
| Widel, M | 1 |
| Eckland, DJ | 1 |
| Gilmore, KJ | 1 |
| Tan, MH | 1 |
| Simsek, E | 1 |
| Kuscu, E | 1 |
| Kendall, DM | 3 |
| Riddle, MC | 1 |
| Zhuang, D | 1 |
| Kim, DD | 3 |
| Ratner, RE | 1 |
| Sartoretto, JL | 1 |
| Melo, GA | 1 |
| Nigro, D | 1 |
| Passaglia, RT | 1 |
| Scavone, C | 1 |
| Cuman, RK | 1 |
| Belcher, G | 1 |
| Lambert, C | 1 |
| Edwards, G | 1 |
| Urquhart, R | 1 |
| Temprosa, M | 1 |
| Fowler, SE | 1 |
| Haffner, SM | 1 |
| Andres, R | 1 |
| Saudek, C | 1 |
| Edelstein, SL | 1 |
| Arakaki, R | 1 |
| Murphy, MB | 1 |
| Shamoon, H | 1 |
| Yilmaz, M | 1 |
| Bukan, N | 1 |
| Ayvaz, G | 1 |
| Karakoç, A | 1 |
| Törüner, F | 1 |
| Cakir, N | 1 |
| Arslan, M | 1 |
| Rosak, C | 1 |
| Petzoldt, R | 1 |
| Wolf, R | 1 |
| Reblin, T | 1 |
| Dehmel, B | 1 |
| Seidel, D | 1 |
| Teede, HJ | 1 |
| Meyer, C | 1 |
| Kvapil, M | 1 |
| Swatko, A | 1 |
| Hilberg, C | 1 |
| Shestakova, M | 1 |
| Kabadi, UM | 1 |
| Kabadi, M | 1 |
| Klein, E | 1 |
| Sankoh, S | 1 |
| Mohideen, P | 1 |
| Zhao, ZS | 1 |
| Lee, YJ | 1 |
| Shim, WS | 1 |
| Kim, SK | 1 |
| Ahn, CW | 1 |
| Park, CW | 1 |
| Kauppinen-Mäkelin, R | 1 |
| Tiikkainen, M | 1 |
| Vähätalo, M | 1 |
| Virtamo, H | 1 |
| Nikkilä, K | 1 |
| Tulokas, T | 1 |
| Hulme, S | 1 |
| Hardy, K | 1 |
| McNulty, S | 1 |
| Hänninen, J | 1 |
| Levänen, H | 1 |
| Lahdenperä, S | 1 |
| Lehtonen, R | 1 |
| Ryysy, L | 1 |
| Chaudhry, ZW | 1 |
| Gannon, MC | 1 |
| Nuttall, FQ | 1 |
| Nichols, GA | 2 |
| Girman, CJ | 1 |
| Kamal-Bahl, SJ | 1 |
| Brown, JB | 1 |
| Klein, EJ | 1 |
| Zhang, B | 1 |
| Mac, SM | 1 |
| Poon, TH | 1 |
| Taylor, KL | 1 |
| Trautmann, ME | 2 |
| de Fine Olivarius, N | 1 |
| Andreasen, AH | 1 |
| Siersma, V | 1 |
| Richelsen, B | 1 |
| Pfützner, A | 1 |
| Schneider, CA | 1 |
| Forst, T | 1 |
| Kautzky-Willer, A | 1 |
| Tura, A | 1 |
| Winzer, C | 1 |
| Wagner, OF | 1 |
| Ludvik, B | 1 |
| Hanusch-Enserer, U | 1 |
| Prager, R | 2 |
| Pacini, G | 1 |
| Yarat, A | 1 |
| Yanardağ, R | 1 |
| Tunali, T | 1 |
| Sacan, O | 1 |
| Gursoy, F | 1 |
| Emekli, N | 1 |
| Ustuner, A | 1 |
| Ergenekon, G | 1 |
| Chadwick, WA | 1 |
| Roux, S | 1 |
| van de Venter, M | 1 |
| Louw, J | 1 |
| Oelofsen, W | 1 |
| Filipczak, R | 1 |
| Le, TD | 1 |
| Gumprecht, J | 1 |
| Hahn, S | 2 |
| Frey, UH | 1 |
| Siffert, W | 1 |
| Tan, S | 2 |
| Janssen, OE | 2 |
| Ong, CR | 1 |
| Molyneaux, LM | 1 |
| Constantino, MI | 1 |
| Twigg, SM | 1 |
| Yue, DK | 1 |
| Kann, PH | 1 |
| Wascher, T | 1 |
| Zackova, V | 1 |
| Moeller, J | 1 |
| Medding, J | 1 |
| Szocs, A | 1 |
| Mokan, M | 1 |
| Mrevlje, F | 1 |
| Regulski, M | 1 |
| Golnik, KC | 1 |
| Aregawi, D | 2 |
| Homan, G | 1 |
| Moran, L | 1 |
| Karim, A | 1 |
| Slater, M | 1 |
| Bradford, D | 1 |
| Schwartz, L | 1 |
| Cao, C | 1 |
| Laurent, A | 1 |
| Gomez-Caminero, A | 1 |
| Ohira, M | 1 |
| Miyashita, Y | 1 |
| Ebisuno, M | 1 |
| Saiki, A | 1 |
| Endo, K | 1 |
| Koide, N | 1 |
| Oyama, T | 1 |
| Murano, T | 1 |
| Watanabe, H | 1 |
| Shirai, K | 1 |
| Schalkwijk, CG | 2 |
| Smidt, UM | 2 |
| Bruno, RV | 1 |
| de Avila, MA | 1 |
| Neves, FB | 1 |
| Nardi, AE | 1 |
| Crespo, CM | 1 |
| Sobrinho, AT | 1 |
| Rangel, N | 1 |
| El Fakih, Y | 1 |
| Uzcátegui, E | 1 |
| Galeazzi, T | 1 |
| Gutiérrez, MA | 1 |
| Servigna, M | 1 |
| Dávila, A | 1 |
| Uzcátegui, M | 1 |
| Serrano, A | 1 |
| Beaulieu, S | 1 |
| Palomba, S | 1 |
| Falbo, A | 1 |
| Russo, T | 1 |
| Manguso, F | 1 |
| Tolino, A | 1 |
| Zullo, F | 1 |
| De Feo, P | 1 |
| Orio, F | 1 |
| Girardin, CM | 1 |
| Schwitzgebel, VM | 1 |
| Ramadan, W | 1 |
| Dewasmes, G | 1 |
| Petitjean, M | 1 |
| Wiernsperger, N | 2 |
| Delanaud, S | 1 |
| Geloen, A | 1 |
| Libert, JP | 1 |
| Marcondes, JA | 1 |
| Yamashita, SA | 1 |
| Halpern, A | 1 |
| Golay, A | 1 |
| Trolle, B | 1 |
| Flyvbjerg, A | 1 |
| Kesmodel, U | 1 |
| Lauszus, FF | 1 |
| Benson, S | 1 |
| Dietz, T | 1 |
| Lahner, H | 1 |
| Moeller, LC | 1 |
| Schmidt, M | 1 |
| Elsenbruch, S | 1 |
| Kimmig, R | 1 |
| Isidro, ML | 1 |
| Penín, MA | 1 |
| Nemiña, R | 1 |
| Cordido, F | 1 |
| Rochotte, E | 1 |
| Cohen, SE | 1 |
| Wu, TH | 1 |
| Liu, HC | 1 |
| Pani, LN | 1 |
| Nathan, DM | 1 |
| Grant, RW | 1 |
| Cho, LW | 1 |
| Krentz, AJ | 1 |
| Burger, J | 1 |
| Brodows, R | 1 |
| Roberts, A | 1 |
| Raz, I | 1 |
| Wu, M | 1 |
| Hussain, S | 1 |
| Kaufman, KD | 1 |
| Amatruda, JM | 1 |
| Langdon, RB | 1 |
| Stein, PP | 1 |
| Loeys, T | 1 |
| Engel, SS | 1 |
| Halperin, F | 1 |
| Ingelfinger, JR | 1 |
| McMahon, GT | 1 |
| Kusaka, I | 1 |
| Nagasaka, S | 1 |
| Horie, H | 1 |
| Ishibashi, S | 1 |
| Neff, LM | 1 |
| Aronne, LJ | 1 |
| Gao, H | 1 |
| Xiao, W | 1 |
| Teerlink, T | 1 |
| Winther, K | 1 |
| Belsey, J | 1 |
| Krishnarajah, G | 1 |
| Elkind-Hirsch, K | 1 |
| Marrioneaux, O | 1 |
| Bhushan, M | 1 |
| Vernor, D | 1 |
| Bhushan, R | 1 |
| Desilets, AR | 1 |
| Dhakal-Karki, S | 1 |
| Dunican, KC | 1 |
| Lean, ME | 1 |
| Borthwick, LJ | 1 |
| Billingham, MS | 1 |
| Hall, RA | 1 |
| Simpson, S | 1 |
| Junien, JL | 1 |
| Chomette, G | 1 |
| Guillaume, M | 1 |
| Wajcman, H | 1 |
| Sterne, J | 1 |
| Muir, A | 1 |
| Howe-Davies, SA | 1 |
| Turner, RC | 1 |
| Zaïbi, MS | 1 |
| Padieu, P | 1 |
| Chessebeuf-Padieu, M | 1 |
| el Baraka, M | 1 |
| Rapin, JR | 1 |
| Rouru, J | 3 |
| Peltonen, J | 1 |
| Santti, E | 2 |
| Hänninen, V | 1 |
| Goodman, AM | 1 |
| Virtanen, K | 1 |
| Rouvari, T | 1 |
| Jhanwar-Uniyal, M | 1 |
| Hermann, LS | 5 |
| Scherstén, B | 1 |
| Bitzén, PO | 1 |
| Kjellström, T | 1 |
| Lindgärde, F | 1 |
| Melander, A | 1 |
| Verma, S | 1 |
| Bhanot, S | 1 |
| McNeill, JH | 1 |
| Landin, K | 1 |
| Tengborn, L | 1 |
| Campbell, IW | 3 |
| Garcia-Honduvilla, J | 1 |
| Martin-Alvarez, PJ | 1 |
| Vara, E | 1 |
| Calle, JR | 1 |
| Munguira, ME | 1 |
| Marañes, JP | 1 |
| Dorella, M | 1 |
| Giusto, M | 1 |
| Campagnolo, M | 1 |
| Palatini, P | 1 |
| Rossi, G | 1 |
| Ceolotto, G | 1 |
| Felice, M | 1 |
| Semplicini, A | 1 |
| Stumvoll, M | 2 |
| Fritsch, A | 1 |
| Grant, PJ | 1 |
| Carlsen, SM | 1 |
| Rossvoll, O | 1 |
| Bjerve, KS | 1 |
| Følling, I | 1 |
| Kosegawa, I | 1 |
| Katayama, S | 1 |
| Kikuchi, C | 1 |
| Kashiwabara, H | 1 |
| Negishi, K | 1 |
| Ishii, J | 1 |
| Inukai, K | 1 |
| Oka, Y | 1 |
| Sreenan, S | 1 |
| Sturis, J | 1 |
| Pugh, W | 1 |
| Burant, CF | 1 |
| Polonsky, KS | 1 |
| Perusicová, J | 1 |
| Cacáková, V | 1 |
| Richtrová, A | 1 |
| Féry, F | 1 |
| Plat, L | 1 |
| Balasse, EO | 1 |
| D'Argenzio, R | 1 |
| Cavallo, P | 1 |
| Merante, D | 2 |
| Morelli, A | 1 |
| Mori, K | 1 |
| Nakamura, J | 1 |
| Koh, N | 1 |
| Sakakibara, F | 1 |
| Hamada, Y | 1 |
| Hara, T | 1 |
| Komori, T | 1 |
| Nakashima, E | 1 |
| Naruse, K | 1 |
| Takeuchi, N | 1 |
| Hotta, N | 1 |
| Briscoe, TA | 1 |
| Anderson, D | 1 |
| Usifo, OS | 1 |
| Cooper, GS | 1 |
| Robinson, AC | 1 |
| Burke, J | 1 |
| Robinson, S | 1 |
| Johnston, DG | 1 |
| Damsbo, P | 1 |
| Hother-Nielsen, O | 1 |
| Reed, MJ | 2 |
| Meszaros, K | 1 |
| Entes, LJ | 1 |
| Claypool, MD | 1 |
| Pinkett, JG | 1 |
| Brignetti, D | 1 |
| Khandwala, A | 1 |
| Yap, WS | 1 |
| Peterson, GM | 1 |
| Vial, JH | 1 |
| Randall, CT | 1 |
| Greenaway, TM | 1 |
| Johansen, K | 1 |
| Swislocki, AL | 1 |
| Khuu, Q | 1 |
| Liao, E | 1 |
| Wu, E | 1 |
| Beza, F | 1 |
| Lopez, J | 1 |
| Kwan, G | 1 |
| Noth, RH | 1 |
| Avilés-Santa, L | 1 |
| Sinding, J | 1 |
| Erle, G | 1 |
| Lovise, S | 1 |
| Stocchiero, C | 1 |
| Lora, L | 1 |
| Coppini, A | 1 |
| Marchetti, P | 1 |
| Yu, JG | 1 |
| Kruszynska, YT | 1 |
| Mulford, MI | 1 |
| Olefsky, JM | 1 |
| Fritsche, A | 1 |
| Schmülling, RM | 1 |
| Lin, HZ | 1 |
| Yang, SQ | 1 |
| Chuckaree, C | 1 |
| Kuhajda, F | 1 |
| Ronnet, G | 1 |
| Diehl, AM | 1 |
| Russell, JC | 1 |
| Ravel, D | 1 |
| Pégorier, JP | 1 |
| Delrat, P | 1 |
| Jochemsen, R | 1 |
| O'Brien, SF | 1 |
| Kelly, SE | 1 |
| Davidge, ST | 1 |
| Brindley, DN | 1 |
| Freemark, M | 1 |
| Bursey, D | 1 |
| Fontaine, RN | 1 |
| Subbiah, MT | 1 |
| Weber, K | 1 |
| Illig, E | 1 |
| Streicher, P | 1 |
| Sieve-Smith, L | 2 |
| Tracy, TM | 1 |
| Lang, JE | 1 |
| McCullough, P | 1 |
| Song, S | 1 |
| Andrikopoulos, S | 1 |
| Filippis, C | 1 |
| Thorburn, AW | 1 |
| Khan, D | 1 |
| Proietto, J | 1 |
| Lehtovirta, M | 1 |
| Forsén, B | 1 |
| Gullström, M | 1 |
| Häggblom, M | 1 |
| Eriksson, JG | 1 |
| Groop, L | 2 |
| Tang, T | 1 |
| Brizi, M | 1 |
| Bianchi, G | 1 |
| Tomassetti, S | 1 |
| Zoli, M | 1 |
| Melchionda, N | 1 |
| Baysal, B | 1 |
| Batukan, M | 1 |
| Batukan, C | 1 |
| Kobayashi, S | 1 |
| Phillips, H | 1 |
| Abbink, EJ | 1 |
| Pickkers, P | 1 |
| Jansen van Rosendaal, A | 1 |
| Lutterman, JA | 1 |
| Russel, FG | 1 |
| Smits, P | 1 |
| Gokcel, A | 1 |
| Gumurdulu, Y | 1 |
| Karakose, H | 1 |
| Melek Ertorer, E | 1 |
| Tanaci, N | 1 |
| BascilTutuncu, N | 1 |
| Guvener, N | 1 |
| Kalén, J | 1 |
| Katzman, P | 1 |
| Lager, I | 1 |
| Nilsson, A | 1 |
| Norrhamn, O | 1 |
| Sartor, G | 1 |
| Ugander, L | 1 |
| Fruehwald-Schultes, B | 1 |
| Oltmanns, KM | 1 |
| Toschek, B | 1 |
| Sopke, S | 1 |
| Kern, W | 1 |
| Born, J | 1 |
| Fehm, HL | 1 |
| Homburg, R | 1 |
| Kiersztan, A | 1 |
| Modzelewska, A | 1 |
| Jarzyna, R | 1 |
| Jagielska, E | 1 |
| Bryła, J | 1 |
| Suzuki, M | 1 |
| Odaka, H | 1 |
| Suzuki, N | 1 |
| Sugiyama, Y | 1 |
| Ikeda, H | 1 |
| Zuhri-Yafi, MI | 1 |
| Brosnan, PG | 1 |
| Hardin, DS | 1 |
| Van Gaal, L | 1 |
| Usadel, KH | 1 |
| Ball, M | 1 |
| Whatmough, I | 1 |
| Guitard, C | 1 |
| Larsen, J | 1 |
| Schneider, SH | 1 |
| Piper, BA | 1 |
| Henry, D | 1 |
| Miles, JM | 1 |
| Leiter, L | 1 |
| Wadden, T | 1 |
| Anderson, JW | 1 |
| Doyle, M | 1 |
| Foreyt, J | 1 |
| Aronne, L | 1 |
| Klein, S | 1 |
| Fedele, D | 1 |
| Tiengo, A | 1 |
| Nosadini, R | 1 |
| Marchiori, E | 1 |
| Briani, G | 1 |
| Garotti, MC | 1 |
| Muggeo, M | 1 |
| Sirtori, CR | 1 |
| Tremoli, E | 1 |
| Sirtori, M | 1 |
| Conti, F | 1 |
| Paoletti, R | 1 |
| Fowler, LK | 1 |
| Clarke, BF | 3 |
| Kemmer, FW | 1 |
| Berger, M | 1 |
| Herberg, L | 1 |
| Gries, FA | 1 |
| Dieterle, C | 1 |
| Streda, M | 1 |
| Cairns, SA | 1 |
| Shalet, S | 1 |
| Marshall, AJ | 1 |
| Hartog, M | 1 |
| Klein, W | 1 |
| Herrmann, A | 1 |
| Hausmann, VL | 1 |
| Schubotz, R | 1 |
| Carpentier, J | 1 |
| Luyckx, AS | 1 |
| Lefebvre, PJ | 1 |
| Brun, JM | 1 |
| Trischitta, V | 1 |
| Italia, S | 1 |
| Mazzarino, S | 1 |
| Buscema, M | 1 |
| Rabuazzo, AM | 1 |
| Sangiorgio, L | 1 |
| Squatrito, S | 1 |
| Vigneri, R | 1 |
| Karlsson, JE | 1 |
| Sjöstrand, A | 1 |
| Isnard, F | 1 |
| André, P | 1 |
| Noury, J | 1 |
| Nandeuil, A | 1 |
| Barzilai, N | 1 |
| Simonson, DC | 1 |
| Dornan, TL | 1 |
| Heller, SR | 1 |
| Peck, GM | 1 |
| Tattersall, RB | 1 |
| Josephkutty, S | 1 |
| Potter, JM | 1 |
| Widén, E | 1 |
| Franssila-Kallunki, A | 1 |
| Ekstrand, A | 1 |
| Saloranta, C | 1 |
| Schalin, C | 1 |
| Eriksson, J | 1 |
| McAlpine, LG | 1 |
| McAlpine, CH | 1 |
| Waclawski, ER | 1 |
| Storer, AM | 1 |
| Kay, JW | 1 |
| Frier, BM | 1 |
| Leslie, P | 1 |
| Jung, RT | 1 |
| Isles, TE | 1 |
| Baty, J | 1 |
| Ewan, C | 1 |
| Graf, H | 1 |
| Duncan, LJ | 2 |
| Lawson, AA | 1 |
| Strong, JA | 1 |
| Peattie, P | 1 |
| Roscoe, P | 1 |
| Gibson, A | 1 |
| Oesch, F | 1 |
| Ohnhaus, EE | 1 |
| Munro, JF | 1 |
| MacCuish, AC | 1 |
| Marshall, A | 1 |
| Wilson, EM | 1 |
| Gustafson, A | 1 |
| Björntorp, P | 1 |
| Fahlén, M | 1 |
| Berchtold, P | 1 |
| Bolli, P | 1 |
| Arbenz, U | 1 |
| Keiser, G | 1 |
| Irsigler, K | 1 |
| Pedersen, J | 1 |
| Olesen, ES | 1 |
| Parrow, A | 1 |
| Haese, E | 1 |
| Berger, W | 1 |
| Constam, GR | 1 |
| Siegenthaler, W | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and [NCT02787551] | Phase 3 | 514 participants (Actual) | Interventional | 2016-07-06 | Completed | ||
| Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed,[NCT03689374] | Phase 3 | 2,274 participants (Actual) | Interventional | 2018-10-01 | Completed | ||
| A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise[NCT03353350] | Phase 3 | 406 participants (Actual) | Interventional | 2017-12-05 | Completed | ||
| Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)[NCT03021187] | Phase 3 | 731 participants (Actual) | Interventional | 2017-02-02 | Completed | ||
| Novel Actions of Metformin to Augment Resistance Training Adaptations in Older Adults[NCT02308228] | Early Phase 1 | 109 participants (Actual) | Interventional | 2015-01-14 | Completed | ||
| Preeclampsia Intervention 4 - A Triple Blind Phase III Randomised Controlled Trial Assessing Metformin to Prolong Gestation in Preterm Preeclampsia[NCT06033131] | Phase 3 | 294 participants (Anticipated) | Interventional | 2024-01-22 | Not yet recruiting | ||
| Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure: A Randomized, Double-blind, Placebo-controlled Study[NCT02810132] | Phase 2 | 36 participants (Actual) | Interventional | 2017-01-20 | Completed | ||
| A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Desp[NCT01159600] | Phase 3 | 1,504 participants (Actual) | Interventional | 2010-07-31 | Completed | ||
| A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With [NCT01289990] | Phase 3 | 2,705 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| A Phase IV, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Effect of 12-week Treatment With the Glucagon-like Peptide-1 Receptor Agonist (GLP-1RA) Liraglutide or Dipeptidyl Peptidase-4 Inhibitor (DPP-4i) Sitagliptin on th[NCT01744236] | Phase 4 | 70 participants (Actual) | Interventional | 2013-04-30 | Completed | ||
| A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS[NCT03538743] | Phase 1 | 98 participants (Actual) | Interventional | 2018-06-25 | Completed | ||
| Effect of Dapagliflozin, Metformin and Physical Activity on Glucose Variability, Body Composition and Cardiovascular Risk in Pre-diabetes[NCT02695810] | Phase 2 | 120 participants (Actual) | Interventional | 2016-02-24 | Completed | ||
| Effectiveness of the Treatment With Dapagliflozin and Metformin Compared to Metformin Monotherapy for Weight Loss on Diabetic and Prediabetic Patients With Obesity Class III[NCT03968224] | Phase 2/Phase 3 | 90 participants (Anticipated) | Interventional | 2018-07-07 | Recruiting | ||
| Family Inclusive Childhood Obesity Treatment Designed for Low Income and Hispanic Families[NCT05041855] | 658 participants (Anticipated) | Interventional | 2021-11-15 | Recruiting | |||
| Type 2 Diabetes Prevention in Community Health Care Settings for at Risk Children and Mothers[NCT03781102] | 120 participants (Anticipated) | Interventional | 2019-07-01 | Suspended (stopped due to COVID19) | |||
| A Randomized, Double-Blind Trial Comparing the Effect of Dulaglutide 1.5 mg With Placebo on Glycemic Control in Patients With Type 2 Diabetes on Basal Insulin Glargine[NCT02152371] | Phase 3 | 300 participants (Actual) | Interventional | 2014-05-31 | Completed | ||
| Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis[NCT04750135] | Phase 2 | 40 participants (Anticipated) | Interventional | 2021-02-07 | Not yet recruiting | ||
| Diazoxide-mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III[NCT00631033] | Phase 2 | 51 participants (Actual) | Interventional | 2008-07-31 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combinatio[NCT01606007] | Phase 3 | 1,282 participants (Actual) | Interventional | 2012-07-31 | Completed | ||
| Efficacy and Safety of Saxagliptin and Glimepiride in Chinese Patients With Type 2 Diabetes Controlled Inadequately With Metformin Monotherapy (SPECIFY Study) : a 48-week, Multi-center, Randomized, Open-label Trial[NCT02280486] | Phase 4 | 388 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
| A Randomized, Blinded, Placebo-Controlled Study To Evaluate The Effect Fixed-Dose Leucine, Metformin, Sildenafil Combinations(NS-0200) Versus Placebo On Hepatic Fat Assessed By MRI In Non Alcoholic Fatty Liver Disease Patients[NCT02546609] | Phase 2 | 91 participants (Actual) | Interventional | 2015-11-19 | Completed | ||
| Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients[NCT05177588] | Phase 4 | 70 participants (Actual) | Interventional | 2021-07-21 | Completed | ||
| Dietary Oxysterols and β-Cell Function Among African Americans[NCT05072587] | 24 participants (Anticipated) | Interventional | 2021-07-01 | Recruiting | |||
| Restoring Insulin Secretion Adult Medication Study[NCT01779362] | Phase 3 | 267 participants (Actual) | Interventional | 2013-04-30 | Completed | ||
| A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes[NCT00909480] | Phase 4 | 457 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| The Relationship Between Baseline Body Weight and Glycemic Control Following Metformin Extended-Release Tablets (Glucophage XR) Monotherapy in Chinese Patients With Newly Diagnosed Type 2 Diabetes[NCT00778622] | Phase 4 | 371 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes W[NCT00673231] | Phase 3 | 1,240 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonyl[NCT00660907] | Phase 3 | 1,217 participants (Actual) | Interventional | 2008-03-31 | Completed | ||
| Feasibility Study of Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease.[NCT02903511] | Phase 2 | 56 participants (Actual) | Interventional | 2016-11-30 | Completed | ||
| Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus[NCT00943917] | Phase 2 | 155 participants (Actual) | Interventional | 2009-08-31 | Completed | ||
| [NCT00004992] | Phase 3 | 3,234 participants (Actual) | Interventional | 1996-07-31 | Completed | ||
| Diabetes Prevention Program Outcomes Study[NCT00038727] | Phase 3 | 2,779 participants (Actual) | Interventional | 2002-09-30 | Active, not recruiting | ||
| Prevalence of Metabolic Syndrome and Effects of Adjunctive Metformin on Metabolic Profiles in Clozapine-treated Schizophrenic Patients[NCT01300637] | 60 participants (Anticipated) | Interventional | 2008-11-30 | Recruiting | |||
| SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation: A Randomised Double-blind Placebo-controlled Trial (The SEESAW Study)[NCT02798744] | Phase 4 | 68 participants (Actual) | Interventional | 2016-12-31 | Completed | ||
| [NCT01245166] | Phase 3 | 220 participants (Anticipated) | Interventional | 2010-11-30 | Recruiting | ||
| A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen: The 'Can Do Ramadan' Study[NCT02694263] | Phase 4 | 25 participants (Actual) | Interventional | 2016-07-31 | Completed | ||
| A Randomized, Double-Blind, Placebo and Active-Controlled, 4-Arm, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Con[NCT01106677] | Phase 3 | 1,284 participants (Actual) | Interventional | 2010-05-31 | Completed | ||
| Effect of Anti-diabetic Drugs on Glycemic Variability. A Comparison Between Gliclazide MR (Modified Release) and Dapagliflozin on Glycemic Variability Measured by Continuous Glucose Monitoring (CGM) in Patients With Uncontrolled Type 2 Diabetes[NCT02925559] | Phase 4 | 135 participants (Actual) | Interventional | 2016-10-31 | Completed | ||
| The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Deformation in Patients With Type 2 Diabetes With High Cardiovascular Risk[NCT03878706] | 240 participants (Anticipated) | Observational [Patient Registry] | 2017-11-03 | Recruiting | |||
| A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate [NCT00984867] | Phase 3 | 833 participants (Actual) | Interventional | 2009-10-31 | Completed | ||
| A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes[NCT01233622] | Phase 3 | 317 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| Efficacy and Safety of the Oral Combined Therapy Glimepiride / Vildagliptin / Metformin in Patients With Type 2 Diabetes With Dual Treatment Failure[NCT04841096] | Phase 3 | 172 participants (Anticipated) | Interventional | 2023-03-21 | Recruiting | ||
| Young Adults With Early-onset Obesity Treated With Semaglutide -The RESETTLE Study[NCT05574439] | Phase 4 | 170 participants (Anticipated) | Interventional | 2022-06-01 | Recruiting | ||
| Research of Exenatide for Management of Reproductive and Metabolic Dysfunction in Overweight/Obese PCOS Patients With Impaired Glucose Regulation[NCT03352869] | Phase 4 | 183 participants (Actual) | Interventional | 2017-11-28 | Completed | ||
| Short Term Weight Loss With Liraglutide and Metformin Before IVF in Infertile Obese PCOS Patients[NCT03034941] | Phase 4 | 35 participants (Actual) | Interventional | 2014-04-30 | Completed | ||
| Effectiveness of the Combination Liraglutide and Metformin on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With Polycystic Ovarian Syndrome, Obesity and Infertility[NCT05952882] | Phase 3 | 188 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting | ||
| Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome: a Prospective, Randomized, Open, Controlled Study[NCT05702905] | Phase 4 | 75 participants (Anticipated) | Interventional | 2023-04-30 | Not yet recruiting | ||
| The Effect of Liraglutide on Pregnancy Rates in Obese Women With PCOS Undergoing in Vitro Fertilization: a Pilot Randomized Study[NCT03353948] | Phase 4 | 30 participants (Actual) | Interventional | 2014-09-01 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin Plus Metformin, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes[NCT01023581] | Phase 3 | 784 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion[NCT02113241] | Phase 2/Phase 3 | 24 participants (Actual) | Interventional | 2014-04-30 | Completed | ||
| A 16-wk, Uni-center, Randomized, Double-blind, Parallel, Phase 3b Trial to Evaluate Efficacy of Saxagliptin + Dapagliflozin vs.Dapagliflozin With Regard to EGP in T2DM With Insufficient Glycemic Control on Metformin+/-Sulfonylurea Therapy[NCT02613897] | 56 participants (Actual) | Interventional | 2016-01-31 | Completed | |||
| Effect of Saxagliptin in Addition to Dapagliflozin and Metformin on Insulin Resistance, Islet Cell Dysfunction, and Metabolic Control in Subjects With Type 2 Diabetes Mellitus on Previous Metformin Treatment[NCT02304081] | Phase 4 | 64 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
| Effect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial[NCT03590626] | 60 participants (Actual) | Interventional | 2019-01-01 | Completed | |||
| The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)[NCT01126580] | Phase 3 | 807 participants (Actual) | Interventional | 2010-05-31 | Completed | ||
| Exercise Snacks and Glutamine to Improve Glucose Control in Adolescents With Type 1 Diabetes[NCT03199638] | 14 participants (Actual) | Interventional | 2016-04-01 | Completed | |||
| A Study of the Effects of Dapagliflozin on Ambulatory Aortic Pressure, Arterial Stiffness and Urine Albumin Excretion in Patients With Type 2 Diabetes[NCT02887677] | Phase 4 | 85 participants (Actual) | Interventional | 2016-10-31 | Terminated (stopped due to On February 2019 Astra-Zeneca Greece decided to stop the financial support of the study.) | ||
| Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes[NCT03132181] | Phase 2 | 40 participants (Actual) | Interventional | 2017-04-24 | Completed | ||
| A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Ins[NCT00960661] | Phase 3 | 1,036 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
| Is the Stepping-down Approach a Better Option Than Multiple Daily Injections in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?[NCT02846233] | 22 participants (Actual) | Interventional | 2016-08-31 | Completed | |||
| Variability of Glucose Assessed in a Randomized Trial Comparing the Initiation of A Treatment Approach With Biosimilar Basal Insulin Analog Or a Titratable iGlarLixi combinatioN in Type 2 Diabetes Among South Asian Subjects (VARIATION 2 SA Trial)[NCT03819790] | Phase 4 | 119 participants (Actual) | Interventional | 2018-10-02 | Completed | ||
| Physicians Committee for Responsible Medicine, A Randomized, Crossover Trial of the Effect of a Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes[NCT04088981] | 60 participants (Anticipated) | Interventional | 2024-07-31 | Suspended (stopped due to The study was not initiated due to COVID-19 restrictions.) | |||
| A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on [NCT01217892] | Phase 3 | 400 participants (Actual) | Interventional | 2010-11-30 | Completed | ||
| A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Co[NCT00968812] | Phase 3 | 1,452 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
| Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine [NCT00331851] | Phase 3 | 584 participants (Actual) | Interventional | 2006-05-31 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise[NCT00528372] | Phase 3 | 1,067 participants (Actual) | Interventional | 2007-09-30 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Ins[NCT00757588] | Phase 3 | 455 participants (Actual) | Interventional | 2008-11-30 | Completed | ||
| A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylure[NCT00575588] | Phase 3 | 891 participants (Actual) | Interventional | 2007-12-31 | Completed | ||
| A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects[NCT00327015] | Phase 3 | 1,306 participants (Actual) | Interventional | 2006-05-31 | Completed | ||
| A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate G[NCT01392677] | Phase 3 | 311 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
| Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin[NCT03076112] | Phase 3 | 170 participants (Actual) | Interventional | 2017-04-25 | Completed | ||
| Prospective, Parallel Goups Study, Aimed to Evaluating Possible Benefits of the Treatment of New Generation Hypoglycaemic Drugs Compared to Sulphonylureas for the Tratment of Type 2 Diabetes Mellitus[NCT04272359] | 138 participants (Anticipated) | Observational [Patient Registry] | 2019-05-06 | Recruiting | |||
| A 12-Week, Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety, Tolerability and Efficacy Of Once Daily PF-04971729 And Sitagliptin On Glycemic Control And Body Weight In Adult Patients With T[NCT01059825] | Phase 2 | 375 participants (Actual) | Interventional | 2010-02-24 | Completed | ||
| FLAT-SUGAR: FLuctuATion Reduction With inSULin and Glp-1 Added togetheR[NCT01524705] | Phase 4 | 102 participants (Actual) | Interventional | 2012-08-31 | Completed | ||
| A Prospective, Randomized, Parallel-group, Adaptive Design Phase IIb/III, Multicenter Study, to Assess the Efficacy of Polychemotherapy for Inducing Remission of Newly Diagnosed Type 2 Diabetes.[NCT04271189] | Phase 2/Phase 3 | 180 participants (Anticipated) | Interventional | 2020-09-01 | Active, not recruiting | ||
| A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Trial of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite a Backgro[NCT01210001] | Phase 3 | 499 participants (Actual) | Interventional | 2010-09-30 | Completed | ||
| The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes[NCT01617434] | Phase 3 | 451 participants (Actual) | Interventional | 2012-09-30 | Completed | ||
| Metformin Versus Insulin in Gestational Diabetes. A Randomized Controlled Single Center Trial.[NCT01240785] | Phase 4 | 221 participants (Actual) | Interventional | 2006-06-30 | Completed | ||
| A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Versus Sitagliptin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformi[NCT01137812] | Phase 3 | 756 participants (Actual) | Interventional | 2010-07-31 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Di[NCT01081834] | Phase 3 | 678 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Met[NCT01106625] | Phase 3 | 469 participants (Actual) | Interventional | 2010-05-31 | Completed | ||
| A Randomized Trial of Metformin as Adjunct Therapy for Overweight Adolescents With Type 1 Diabetes[NCT01881828] | Phase 3 | 164 participants (Actual) | Interventional | 2013-09-30 | Completed | ||
| The Effect of Metformin Versus Placebo, Including Three Insulin-Analogue Regimens With Variating Postprandial Glucose Regulation, on CIMT in T2DM Patients - A Randomized, Multicenter Trial[NCT00657943] | Phase 4 | 415 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Contr[NCT01106651] | Phase 3 | 716 participants (Actual) | Interventional | 2010-06-30 | Completed | ||
| The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes.(LIRA-DPP-4 CHINA™)[NCT02008682] | Phase 4 | 368 participants (Actual) | Interventional | 2013-12-31 | Completed | ||
| A Double-blind [Sponsor Unblinded], Randomized, Placebo-controlled, Staggered-parallel Study to Investigate the Safety, Tolerability, and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes[NCT01725126] | Phase 2 | 53 participants (Actual) | Interventional | 2013-02-10 | Completed | ||
| Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial[NCT00081328] | Phase 3 | 699 participants (Actual) | Interventional | 2004-05-31 | Completed | ||
| Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes[NCT05653518] | 40 participants (Anticipated) | Interventional | 2023-09-09 | Recruiting | |||
| A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficien[NCT01768559] | Phase 3 | 894 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| A Multicenter, Randomized, Double Blind Study to Compare the Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (Janumet®) Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus[NCT00993187] | Phase 4 | 292 participants (Actual) | Interventional | 2010-05-04 | Completed | ||
| A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients[NCT01476475] | Phase 2 | 323 participants (Actual) | Interventional | 2011-11-30 | Completed | ||
| Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes[NCT01973231] | Phase 4 | 404 participants (Actual) | Interventional | 2013-10-31 | Completed | ||
| Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin[NCT01907854] | Phase 4 | 407 participants (Actual) | Interventional | 2013-12-02 | Completed | ||
| Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk[NCT02028221] | Phase 2 | 151 participants (Actual) | Interventional | 2014-03-07 | Completed | ||
| Investigation of Pharmacodynamic and Pharmacokinetic Interactions Between 25 mg BI 10773 and 25 mg Hydrochlorothiazide or 5 mg Torasemide Under Steady State Conditions in Patients With Type 2 Diabetes Mellitus in an Open-label, Randomised, Cross-over Tria[NCT01276288] | Phase 1 | 23 participants (Actual) | Interventional | 2011-01-31 | Completed | ||
| Open-label, Flexible-dose Adjunctive Bromocriptine for Patients With Schizophrenia and Impaired Glucose Tolerance[NCT03575000] | Phase 4 | 20 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting | ||
| Treatment of Metabolic Abnormalities in Patients With Schizophrenia: Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities[NCT02751307] | Phase 4 | 55 participants (Actual) | Interventional | 2013-05-31 | Completed | ||
| [NCT02909933] | Phase 4 | 30 participants (Actual) | Interventional | 2015-07-31 | Completed | ||
| Phase II Randomized Study of Neoadjuvant Metformin Plus Letrozole vs Placebo Plus Letrozole for ER-positive Postmenopausal Breast Cancer[NCT01589367] | Phase 2 | 208 participants (Actual) | Interventional | 2012-05-31 | Completed | ||
| Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (T1D)--Insulin Clamp Ancillary Study for Assessment of Insulin Resistance[NCT02045290] | Phase 3 | 37 participants (Actual) | Interventional | 2014-01-31 | Completed | ||
| Effect of Metformin On Glycaemic Control and Non-Glycaemic Cardiovascular Risk-Factors in Patients With Type-1 Diabetes, With Long-Standing Inadequate Glycaemic Control by Insulin and Diet[NCT00118937] | Phase 4 | 100 participants (Actual) | Interventional | 2003-12-31 | Completed | ||
| The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives[NCT00428311] | Phase 4 | 50 participants | Interventional | 2004-04-30 | Completed | ||
| A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia[NCT00379769] | Phase 3 | 4,447 participants (Actual) | Interventional | 2001-04-30 | Completed | ||
| Use of Metformin in Prevention and Treatment of Cardiac Fibrosis in PAI-1 Deficient Population[NCT05317806] | Phase 4 | 15 participants (Anticipated) | Interventional | 2022-10-10 | Active, not recruiting | ||
| Evolution of Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin, in Association With Metformin or Sulfonylurea.[NCT00159211] | 28 participants (Actual) | Interventional | 2005-05-31 | Terminated (stopped due to inclusion was finished) | |||
| A Phase III, Randomized, Parallel, Double-blind, and Non-inferiority Clinical Trial to Compare Efficacy and Safety of CinnaGen-liraglutide to Innovator Liraglutide Product (Victoza®) in Patients With Type II Diabetes (T2D)[NCT03421119] | Phase 3 | 300 participants (Anticipated) | Interventional | 2019-06-20 | Not yet recruiting | ||
| Does Metformin Improve Pregnancy Outcomes (Incidence of LGA (≥90% Birth Weight Centile) Babies, Onset of Maternal GDM, Hypertension, PET, Macrosomia, Shoulder Dystocia, Admission to SCBU) in Obese Non-diabetic Women?[NCT01273584] | Phase 2/Phase 3 | 450 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.[NCT00325364] | Phase 3 | 415 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
| Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.[NCT04626089] | Phase 2 | 0 participants (Actual) | Interventional | 2021-02-28 | Withdrawn (stopped due to Administrative decision of the company) | ||
| Dipeptidyl Peptidase-4 Inhibition and Narrow-band Ultraviolet-B Light in Psoriasis (DINUP): A Randomised Clinical Trial[NCT02347501] | Phase 2 | 118 participants (Actual) | Interventional | 2013-11-30 | Completed | ||
| Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.[NCT01991197] | Phase 2 | 20 participants (Actual) | Interventional | 2014-04-30 | Completed | ||
| The Impact of Glucose Lowering Therapies Including Dipeptidyl Peptidase-4 Inhibitor on Circulating Endothelial Progenitor Cells (EPCs) and Its Mobilising Factor Stromal Derived Factor-1α (SDF-1α) in Patients With Type 2 Diabetes[NCT02694575] | 241 participants (Actual) | Observational | 2015-03-01 | Completed | |||
| A Pilot Study: Metformin as an Inflammatory Modulating Therapy in Older Adults Without Diabetes[NCT03772964] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2019-01-22 | Completed | ||
| Effects of the PPAR-gamma Agonist Pioglitazone on Renal and Hormonal Responses to Salt in Diabetic and Hypertensive Subjects[NCT01090752] | Phase 4 | 16 participants (Actual) | Interventional | 2005-10-31 | Completed | ||
| Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (METS) - Pilot Study[NCT00816907] | Phase 4 | 146 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
| A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications[NCT00765817] | Phase 3 | 261 participants (Actual) | Interventional | 2008-10-31 | Completed | ||
| Effects of Metformin on Energy Intake, Energy Expenditure, and Body Weight in Overweight Children With Insulin Resistance[NCT00005669] | Phase 2 | 100 participants (Actual) | Interventional | 2000-05-31 | Completed | ||
| Exenatide BID Compared With Insulin Glargine to Change Liver Fat Content in Non-alcoholic Fatty-liver Disease Patients With Type 2 Diabetes[NCT02303730] | Phase 4 | 76 participants (Actual) | Interventional | 2015-03-31 | Completed | ||
| A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metfor[NCT00097500] | Phase 3 | 69 participants (Actual) | Interventional | 2004-09-30 | Completed | ||
| Effect of Exenatide Treatment on Hepatic Fat Content and Plasma Adipocytokine Levels in Patients With Type 2 Diabetes Mellitus[NCT01432405] | Phase 4 | 24 participants (Actual) | Interventional | 2007-06-30 | Completed | ||
| A Multicentre Observational Study to Investigate the Improvement in Glucose FLuctuation of Sufficient Acarbose Therapy on Type 2 Diabetes Patient With High Blood Glucose Fluctuation[NCT03805191] | 900 participants (Anticipated) | Observational | 2019-01-01 | Recruiting | |||
| Phase 4 Study Evaluation of the Effects of Acarbose Versus Glibenclamide on Mean Amplitude of Glycemic Excursions and Oxidative Stress in Patients With Type 2 Diabetes Insufficiently Controlled by Metformin[NCT00417729] | Phase 4 | 51 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS Study)[NCT02577159] | Phase 4 | 50 participants (Anticipated) | Interventional | 2015-07-01 | Active, not recruiting | ||
| ORAL ANTIDIABETICS EFFECT ON VISCERAL FAT MEASURED BY BIOIMPEDANCE IN TYPE 2 DIABETES PATIENTS. Pilot Study.[NCT05032001] | 30 participants (Anticipated) | Interventional | 2021-08-01 | Enrolling by invitation | |||
| Effect of the Combination of Dipeptidyl Peptidase-4 Inhibitor (DPP4i) and Insulin in Comparison to Insulin on Metabolic Control and Prognosis in Hospitalized Patients With COVID-19[NCT04542213] | Phase 3 | 70 participants (Actual) | Interventional | 2020-08-01 | Completed | ||
| DPP-4 Inhibitors in Patients With Type 2 Diabetes and Acute Myocardial Infarction:Effects on Platelet Function[NCT02377388] | Phase 3 | 74 participants (Actual) | Interventional | 2017-02-07 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin Monotherapy and Metformin Monoth[NCT00643851] | Phase 3 | 994 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
| An Open-Label Study to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety of AC2993 Given Two Times a Day to Subjects With Type 2 Diabetes Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination[NCT00044668] | Phase 3 | 155 participants (Actual) | Interventional | 2002-08-31 | Completed | ||
| Superiority Study of Insulin Glargine Over Sitagliptin in Insulin-naïve Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled[NCT00751114] | Phase 4 | 515 participants (Actual) | Interventional | 2008-11-30 | Completed | ||
| The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Ext[NCT00700817] | Phase 3 | 665 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
| Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes: A 12-week Randomized Clinical Study[NCT02686476] | 100 participants (Actual) | Interventional | 2016-03-31 | Completed | |||
| Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation: a Randomized Controlled Trial[NCT05042505] | 100 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting | |||
| Gastric Tolerability and Pharmacokinetics of an Extended Release Metformin and an Immediate Release Metformin[NCT00941239] | Phase 1 | 24 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| Double-blind, Randomized Clinical Trial to Evaluate Effect of Combination Therapy of Metformin and Sibutramine Versus Metformin or Sibutramine Monotherapy Over Weight, Adiposity, Glucose Metabolism and Inflammatory State in Obese Patients[NCT00941382] | Phase 3 | 60 participants (Anticipated) | Interventional | 2008-11-30 | Active, not recruiting | ||
| Clinical Metabolic and Endocrine Parameters in Response to Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome: A Phase 4 Randomized, Double- Blind and Placebo Control Trial[NCT00679679] | Phase 4 | 30 participants (Actual) | Interventional | 2003-01-31 | Completed | ||
| Effect of Metformin on Healthy Live Birth After In-vitro Fertilization in Women With Prediabetes Mellitus: a Multicenter Double-blind Placebo Controlled Randomized Trial[NCT06064669] | 988 participants (Anticipated) | Interventional | 2023-10-01 | Not yet recruiting | |||
| Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy[NCT00598793] | Phase 3 | 242 participants (Actual) | Interventional | 2002-11-30 | Completed | ||
| Modulation of Insulin Secretion and Insulin Sensitivity in Bangladeshi Type 2 Diabetic Subjects by an Insulin Sensitizer Pioglitazone and T2DM Association With PPARG Gene Polymorphism.[NCT01589445] | Phase 4 | 77 participants (Actual) | Interventional | 2008-11-30 | Completed | ||
| A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Twice Daily in Subjects With Type 2 Diabetes Mellitus Treated With Metformin and a Sulfo[NCT00035984] | Phase 3 | 734 participants (Actual) | Interventional | 2002-05-31 | Completed | ||
| A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With Metformin Alone[NCT00039013] | Phase 3 | 336 participants (Actual) | Interventional | 2002-03-31 | Completed | ||
| Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide[NCT00569907] | 18 participants (Actual) | Observational | 2007-01-31 | Completed | |||
| Phase IV Study of Ramelteon as an Adjunct Therapy in Non-Diabetic Patients With Schizophrenia[NCT00595504] | Phase 4 | 25 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
| Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia[NCT01082588] | Phase 4 | 60 participants (Actual) | Interventional | 2010-06-30 | Completed | ||
| Basal Insulin Therapy in Patients With Insulin Resistance: A 6 Month Comparison of Insulin Glargine and NPH Insulin[NCT01854723] | Phase 4 | 0 participants (Actual) | Interventional | 2013-04-30 | Withdrawn | ||
| Comparison of Carbohydrate Metabolism During the Night and at Hypoglycemia in Type-2 Diabetic Patients Either on Glargine or NPH Insulin[NCT00468364] | 12 participants (Actual) | Observational | 2003-07-31 | Completed | |||
| Bedtime Insulin Glargine or Bedtime Neutral Protamine Lispro Combined With Sulfonylurea and Metformin in Type 2 Diabetes. A Randomized, Controlled Trial[NCT00641407] | Phase 4 | 100 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus[NCT00111540] | Phase 3 | 456 participants (Actual) | Interventional | 2002-11-30 | Completed | ||
| Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus[NCT01761318] | Phase 4 | 50 participants (Actual) | Interventional | 2013-11-30 | Completed | ||
| Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Doubl[NCT01511172] | Phase 2 | 145 participants (Actual) | Interventional | 2002-08-31 | Completed | ||
| Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes[NCT00619697] | Phase 4 | 260 participants (Actual) | Interventional | 2003-12-31 | Completed | ||
| Descriptive, Transversal Study of Evaluation of Cardiovascular Risks Factors and Prevalence of Metabolic Syndrome in the Different Phenotypes of Women With Polycystic Ovary Syndrome[NCT00784615] | 80 participants (Anticipated) | Observational | 2007-12-31 | Recruiting | |||
| Randomized, Cross-over Trial With Metformin in Women With Polycystic Ovary Syndrome[NCT02280057] | Phase 4 | 56 participants (Actual) | Interventional | 2001-09-30 | Completed | ||
| Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes[NCT00237237] | Phase 3 | 588 participants | Interventional | 2005-10-31 | Completed | ||
| Effects of Sitagliptin on Postprandial Glycaemia, Incretin Hormones and Blood Pressure in Type 2 Diabetes - Relationship to Gastric Emptying[NCT02324010] | Phase 2 | 14 participants (Actual) | Interventional | 2015-07-31 | Completed | ||
| Efficacy and Safety of Add-on Topiramate vs Metformin on Cardio-Metabolic Profile in Patients With Schizophrenia on Atypical Antipsychotics With Metabolic Syndrome: a Randomized Controlled Trial[NCT05663749] | Phase 4 | 60 participants (Actual) | Interventional | 2022-09-20 | Completed | ||
| A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy[NCT00337610] | Phase 3 | 190 participants (Actual) | Interventional | 2006-06-30 | Completed | ||
| Efficacy, Safety & Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus[NCT05556291] | 190 participants (Anticipated) | Observational | 2022-12-01 | Recruiting | |||
| [NCT00684528] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 2008-06-30 | Recruiting | ||
| A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy[NCT00541775] | Phase 3 | 273 participants (Actual) | Interventional | 2006-06-30 | Completed | ||
| Effects of Triple Drug Cocktail Therapy on Metabolic, Endocrine Alterations and Perceived Stress Response in Patients With PCOS: A Double Blind Randomized Clinical Trial[NCT04113889] | Phase 2 | 147 participants (Actual) | Interventional | 2019-10-15 | Completed | ||
| Comparison of the Effects of Monotherapy With Exenatide or Metformin to Combined Exenatide and Metformin Therapy on Menstrual Cyclicity in Overweight Women With Polycystic Ovary Syndrome[NCT00344851] | Phase 2 | 60 participants (Actual) | Interventional | 2006-06-30 | Completed | ||
| Metformin Pharmacology in Human Cancers[NCT03477162] | Early Phase 1 | 18 participants (Actual) | Interventional | 2018-05-15 | Terminated (stopped due to Enrollment was closed as efforts had become more challenging, and the lab indicated that they were able to obtain their primary objective with the number that had already been enrolled.) | ||
| A Randomized Phase 3 Trial of Metformin in Patients Initiating Androgen Deprivation Therapy as Prevention and Intervention of Metabolic Syndrome: The Prime Study[NCT03031821] | Phase 3 | 168 participants (Actual) | Interventional | 2018-07-12 | Terminated (stopped due to Manufacturer discontinued the production of study drugs.) | ||
| A Randomized, Placebo-controlled, Double-blind Multicenter Phase II Study to Investigate the Protectivity and Efficacy of Metformin Against Steatosis in Combination With FOLFIRI and Cetuximab in Subjects With First-line Palliative Treated, KRAS-Wild-Type,[NCT01523639] | Phase 2 | 8 participants (Actual) | Interventional | 2012-04-30 | Terminated (stopped due to Prematurely due to slow recruitment (07/08/2013). Newly defined study end=LPLV=05/11/2013. ABCSG guaranteed completed treatment period for ethical reasons.) | ||
| Double-blind Randomized Trial Using Oral Metformin Versus Placebo in the Treatment of Acanthosis Nigricans in Children With Obesity[NCT02438020] | Phase 4 | 30 participants (Anticipated) | Interventional | 2015-06-30 | Not yet recruiting | ||
| Randomized Clinical Trial, Effect of Metformin and Rosiglitazone Over Glucose Homeoastasis in no Diabetic With Metabolic Syndrome Patients.[NCT04148183] | Phase 2/Phase 3 | 30 participants (Actual) | Interventional | 2004-01-01 | Completed | ||
| Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)[NCT00845845] | Phase 2 | 12 participants (Actual) | Interventional | 2006-03-31 | Terminated (stopped due to Terminated due to low enrollment.) | ||
| Effects of Metformin on Fertility and Pregnancy in Women With Polycystic Ovary Syndrome: a Randomized, Prospective, Placebo-controlled Multicenter Study[NCT00994812] | Phase 3 | 326 participants (Actual) | Interventional | 2002-08-31 | Completed | ||
| Open-Label Study Of Metformin In Combination With Simvastatin For Men With Prostate Carcinoma And A Rising Serum Prostate-Specific Antigen Level After Radical Prostatectomy And/Or Radiation Therapy[NCT01561482] | Phase 2 | 0 participants (Actual) | Interventional | 2012-01-31 | Withdrawn (stopped due to Study closed due to slow/low enrollment; no subjects were enrolled.) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. (NCT02787551)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -1.51 |
| GLP-1 Receptor Agonist | -0.52 |
2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF. (NCT02787551)
Timeframe: Baseline, Week 52
| Intervention | mmol/L (Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -1.85 |
The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF). (NCT02787551)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -3.96 |
| GLP-1 Receptor Agonist | -1.11 |
The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF. (NCT02787551)
Timeframe: Baseline, Week 52
| Intervention | mmol/L (Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -4.30 |
Change in body weight was calculated by subtracting baseline value from Week 26 value. (NCT02787551)
Timeframe: Baseline, Week 26
| Intervention | kilogram (kg) (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | 1.89 |
| GLP-1 Receptor Agonist | -1.14 |
Change in body weight was calculated by subtracting baseline value from Week 52 value. (NCT02787551)
Timeframe: Baseline, Week 52
| Intervention | kg (Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | 2.78 |
Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period. (NCT02787551)
Timeframe: Baseline, Week 26
| Intervention | millimoles per litre (mmol/L) (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -2.28 |
| GLP-1 Receptor Agonist | -0.60 |
Change in FPG was calculated by subtracting baseline value from Week 52 value. (NCT02787551)
Timeframe: Baseline, Week 52
| Intervention | mmol/L (Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -2.27 |
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period. (NCT02787551)
Timeframe: Baseline, Week 26
| Intervention | percentage of HbA1c (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -1.02 |
| GLP-1 Receptor Agonist | -0.38 |
Change in HbA1c was calculated by subtracting baseline value from Week 52 value. (NCT02787551)
Timeframe: Baseline, Week 52
| Intervention | percentage of HbA1c (Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -1.01 |
The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period. (NCT02787551)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -1.69 |
| GLP-1 Receptor Agonist | -0.67 |
The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. (NCT02787551)
Timeframe: Baseline, Week 52
| Intervention | mmol/L (Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -1.68 |
Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%. (NCT02787551)
Timeframe: From Baseline to Week 26
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | 4.8 |
| GLP-1 Receptor Agonist | 15.0 |
Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%. (NCT02787551)
Timeframe: From Week 26 to Week 52
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | 1.5 |
Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed. (NCT02787551)
Timeframe: From Baseline to Week 26
| Intervention | events per participant-year (Number) | |
|---|---|---|
| Documented symptomatic hypoglycemia(<=3.9 mmol/L) | Documented symptomatic hypoglycemia (<3.0 mmol/L) | |
| GLP-1 Receptor Agonist | 0.08 | 0.01 |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | 1.54 | 0.25 |
Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed. (NCT02787551)
Timeframe: From Baseline to Week 52
| Intervention | events per participant-year (Number) | |
|---|---|---|
| Documented symptomatic hypoglycemia(<=3.9 mmol/L) | Documented symptomatic hypoglycemia (<3.0 mmol/L) | |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | 1.59 | 0.24 |
Participants without any available HbA1c assessment at Week 52 were considered as non-responders. (NCT02787551)
Timeframe: Week 52
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HbA1c <7% | HbA1c <=6.5% | |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | 64.1 | 42.7 |
Participants without any available HbA1c assessment at Week 26 were considered as non-responders. (NCT02787551)
Timeframe: Week 26
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HbA1c <7% | HbA1c <=6.5% | |
| GLP-1 Receptor Agonist | 25.7 | 9.9 |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | 61.9 | 40.5 |
Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Percentage of HbA1c (Mean) |
|---|---|
| Semaglutide | -1.5 |
| Insulin Aspart | -1.2 |
Change from baseline in 7-point self-measured plasma glucose profile: mean 7-PP at week 52 is presented. All participants were instructed to perform 7-point SMPG profiles before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal (dinner), 90 minutes after the start of main evening meal (dinner) and at bedtime. The measurements were to be performed before any injection of bolus insulin and just before the start of the meal (breakfast, lunch or main evening meal), and values measured before breakfast were performed in a fasting condition. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | mmol/L (Mean) |
|---|---|
| Semaglutide | -2.1 |
| Insulin Aspart | -2.1 |
Change from baseline in 7-point SMPG profile: mean post-prandial increment (over all meals) at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | mmol/L (Mean) |
|---|---|
| Semaglutide | -0.7 |
| Insulin Aspart | -0.9 |
Change from baseline in BMI at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | kilograms per meter square (kg/m^2) (Mean) |
|---|---|
| Semaglutide | -1.5 |
| Insulin Aspart | 1.0 |
Change from baseline in body weight at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | kilograms (Mean) |
|---|---|
| Semaglutide | -4.2 |
| Insulin Aspart | 2.9 |
Change from baseline in body weight (measured in percentage) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Ratio of body weight (Mean) |
|---|---|
| Semaglutide | 1.0 |
| Insulin Aspart | 1.0 |
Change from baseline in HDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Ratio of HDL cholesterol (Geometric Mean) |
|---|---|
| Semaglutide | 1.0 |
| Insulin Aspart | 1.0 |
Change from baseline in LDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Ratio of LDL cholesterol (Geometric Mean) |
|---|---|
| Semaglutide | 1.0 |
| Insulin Aspart | 1.0 |
Change from baseline in total cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Ratio of total cholesterol (Geometric Mean) |
|---|---|
| Semaglutide | 1.0 |
| Insulin Aspart | 1.0 |
Change from baseline in triglycerides (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Ratio of triglycerides (Geometric Mean) |
|---|---|
| Semaglutide | 0.9 |
| Insulin Aspart | 1.0 |
Change from baseline in FPG at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | millimoles per liter (mmol/L) (Mean) |
|---|---|
| Semaglutide | -1.3 |
| Insulin Aspart | -0.8 |
Change from baseline in pulse rate at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Beats per minute (beats/min) (Mean) |
|---|---|
| Semaglutide | 2.2 |
| Insulin Aspart | 1.1 |
Change from baseline in waist circumference at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | centimeters (cm) (Mean) |
|---|---|
| Semaglutide | -3.3 |
| Insulin Aspart | 2.1 |
Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: At week 52
| Intervention | Units of insulin (Mean) |
|---|---|
| Semaglutide | 35.8 |
| Insulin Aspart | 40.7 |
Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52
| Intervention | Episodes (Number) |
|---|---|
| Semaglutide | 254 |
| Insulin Aspart | 1744 |
Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration <= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52
| Intervention | Episodes (Number) |
|---|---|
| Semaglutide | 1420 |
| Insulin Aspart | 5616 |
Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose < 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose < 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52
| Intervention | Episodes (Number) |
|---|---|
| Semaglutide | 339 |
| Insulin Aspart | 2270 |
Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52
| Intervention | Episodes (Number) |
|---|---|
| Semaglutide | 4 |
| Insulin Aspart | 7 |
Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) to week 52
| Intervention | Episodes (Number) |
|---|---|
| Semaglutide | 2 |
| Insulin Aspart | 4 |
First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) up to week 52
| Intervention | First event per 100 years of exposure (Number) |
|---|---|
| Semaglutide | 0.4 |
| Insulin Aspart | 0.7 |
First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: From randomization (week 0) up to week 52
| Intervention | First event per 100 years of exposure (Number) |
|---|---|
| Semaglutide | 0.2 |
| Insulin Aspart | 0.4 |
Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: At week 52
| Intervention | Units of insulin (Mean) |
|---|---|
| Semaglutide | 35.8 |
| Insulin Aspart | 77.7 |
SF-36v2 is 36-item patient-reported survey of patient health to measure participant's overall health-related quality of life (HRQoL). It has 36 items: 8 domains of physical, mental health status (physical functioning, role physical health (range:21.23-57.16), bodily pain (range: 21.68-62.00), general health (range: 18.95-66.50), vitality (range: 22.89-70.42), social functioning (range: 17.23-57.34), role emotional problem (range: 14.39-56.17) and mental health (range: 11.63-63.95)) and 2 total summary scores: physical components summary (range: 7.32-70.14) and mental components summary (range: 5.79-69.91) calculated from domain scores. All 10 scores range from 5.79-70.42 . Higher scores indicated a better health state. Change from baseline in SF-36v2, 2 summary and 8 domains scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from date of first dose of trial product (week 0) to last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Scores on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Physical Component Summary | Mental Component Summary | Physical Functioning | Role Physical Health | Bodily Pain | General Health | Vitality | Social Functioning | Role Emotional Problem | Mental Health | |
| Insulin Aspart | 0.4 | -0.3 | 0.2 | -0.2 | 0.8 | 0.3 | 0.1 | -0.6 | -0.2 | 0.1 |
| Semaglutide | 1.4 | 0.1 | 1.4 | 0.1 | 1.5 | 1.6 | 1.1 | 0.2 | 0.0 | 0.6 |
The DQLCTQ-R questionnaire was used to assess participants' HRQoL. The DQLCTQ-R questionnaire contains 57 items and measures and provide scores for the 8 domains (physical function, energy or fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility and frequency of symptoms). The 8 domain scores related to DQLCTQ-R are measured on a scale from 0-100. For all scores, higher values indicated better health status. Change from baseline in DQLCTQ-R 8 domain scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | Scores on a scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Physical function | Energy or fatigue | Health distress | Mental health | Satisfaction | Treatment satisfaction | Treatment flexibility | Frequency of symptoms | |
| Insulin Aspart | -0.4 | 0.4 | 0.3 | 0.5 | -0.2 | 0.8 | -1.2 | 1.8 |
| Semaglutide | 2.4 | 2.3 | -0.2 | 7.2 | 4.1 | 9.9 | 4.2 | 4.1 |
Change from baseline in systolic and diastolic blood pressure at week 52 are presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). (NCT03689374)
Timeframe: Baseline (week 0), week 52
| Intervention | millimeter of mercury (mmHg) (Mean) | |
|---|---|---|
| Diastolic Blood Pressure | Systolic Blood Pressure | |
| Insulin Aspart | -0.4 | 1.0 |
| Semaglutide | -1.4 | -2.8 |
Change from Baseline to Week 30 in body weight (NCT03353350)
Timeframe: Baseline to Week 30
| Intervention | kg (Mean) |
|---|---|
| Placebo | -1.35 |
| Efpeglenatide 2 mg | -1.01 |
| Efpeglenatide 4 mg | -3.34 |
| Efpeglenatide 6 mg | -3.19 |
Change from Baseline to Week 56 in body weight (NCT03353350)
Timeframe: Baseline to Week 56
| Intervention | kg (Mean) |
|---|---|
| Placebo | -1.26 |
| Efpeglenatide 2 mg | -0.94 |
| Efpeglenatide 4 mg | -3.24 |
| Efpeglenatide 6 mg | -1.82 |
Change from Baseline to Week 30 in FPG (NCT03353350)
Timeframe: Baseline to Week 30
| Intervention | FPG (mmol/L) (Mean) |
|---|---|
| Placebo | 8.59 |
| Efpeglenatide 2 mg | -0.87 |
| Efpeglenatide 4 mg | 6.84 |
| Efpeglenatide 6 mg | 6.55 |
Change from Baseline to Week 30 in HbA1c (NCT03353350)
Timeframe: Baseline to Week 30
| Intervention | HbA1c (%) (Mean) |
|---|---|
| Placebo | -0.46 |
| Efpeglenatide 2 mg | -1.14 |
| Efpeglenatide 4 mg | -1.48 |
| Efpeglenatide 6 mg | -1.59 |
Change from Baseline to Week 56 in HbA1c (NCT03353350)
Timeframe: Baseline to Week 56
| Intervention | HbA1c (%) (Mean) |
|---|---|
| Placebo | -0.52 |
| Efpeglenatide 2 mg | -1.18 |
| Efpeglenatide 4 mg | -1.51 |
| Efpeglenatide 6 mg | -1.51 |
Number of participants with HbA1c <7.0% at Week 30 (NCT03353350)
Timeframe: Week 30
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 26 |
| Efpeglenatide 2 mg | 60 |
| Efpeglenatide 4 mg | 66 |
| Efpeglenatide 6 mg | 76 |
Number of hypoglycemic events (NCT03353350)
Timeframe: Baseline to Week 56
| Intervention | Number of events (Number) |
|---|---|
| Placebo | 2 |
| Efpeglenatide 2 mg | 10 |
| Efpeglenatide 4 mg | 14 |
| Efpeglenatide 6 mg | 14 |
Number of participants with at least 1 hypoglycemic event during treatment period (NCT03353350)
Timeframe: Baseline to Week 56
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 2 |
| Efpeglenatide 2 mg | 10 |
| Efpeglenatide 4 mg | 14 |
| Efpeglenatide 6 mg | 14 |
Number of participants with TEAEs (NCT03353350)
Timeframe: Baseline to Week 56
| Intervention | Number of Treatment Emergent AEs (Number) |
|---|---|
| Placebo | 79 |
| Efpeglenatide 2 mg | 80 |
| Efpeglenatide 4 mg | 79 |
| Efpeglenatide 6 mg | 83 |
Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 52
| Intervention | Kg (Mean) |
|---|---|
| Oral Semaglutide 3 mg | -0.9 |
| Oral Semaglutide 7 mg | -2.2 |
| Oral Semaglutide 14 mg | -3.8 |
| Placebo | 0.5 |
Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 52
| Intervention | Percentage of HbA1c (Mean) |
|---|---|
| Oral Semaglutide 3 mg | -0.6 |
| Oral Semaglutide 7 mg | -0.9 |
| Oral Semaglutide 14 mg | -1.2 |
| Placebo | -0.2 |
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Weeks 0-57
| Intervention | Events (Number) |
|---|---|
| Oral Semaglutide 3 mg | 626 |
| Oral Semaglutide 7 mg | 555 |
| Oral Semaglutide 14 mg | 586 |
| Placebo | 464 |
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. (NCT03021187)
Timeframe: Weeks 0-57
| Intervention | Episodes (Number) |
|---|---|
| Oral Semaglutide 3 mg | 196 |
| Oral Semaglutide 7 mg | 180 |
| Oral Semaglutide 14 mg | 147 |
| Placebo | 156 |
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. (NCT03021187)
Timeframe: Weeks 0-57
| Intervention | Participants (Count of Participants) |
|---|---|
| Oral Semaglutide 3 mg | 52 |
| Oral Semaglutide 7 mg | 47 |
| Oral Semaglutide 14 mg | 48 |
| Placebo | 54 |
Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Ratio of amylase (Geometric Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | 1.14 | 1.17 |
| Oral Semaglutide 3 mg | 1.08 | 1.07 |
| Oral Semaglutide 7 mg | 1.12 | 1.11 |
| Placebo | 1.01 | 0.99 |
Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | kg/m^2 (Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | -1.4 | -1.4 |
| Oral Semaglutide 3 mg | -0.5 | -0.3 |
| Oral Semaglutide 7 mg | -1.0 | -0.8 |
| Placebo | -0.2 | 0.2 |
Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Percentage change (Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | -4.30 | -4.42 |
| Oral Semaglutide 3 mg | -1.73 | -1.18 |
| Oral Semaglutide 7 mg | -3.11 | -2.54 |
| Placebo | -0.47 | 0.65 |
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26
| Intervention | Kg (Mean) | |
|---|---|---|
| In trial | On-treatment without rescue medication | |
| Oral Semaglutide 14 mg | -3.7 | -3.9 |
| Oral Semaglutide 3 mg | -1.4 | -1.5 |
| Oral Semaglutide 7 mg | -2.6 | -3.0 |
| Placebo | -0.5 | -0.5 |
"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction." (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Score on a scale (Mean) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Satisfaction with treatment: wk 26 | Satisfaction with treatment: wk 52 | Feeling of unacceptably high blood sugars: wk 26 | Feeling of unacceptably high blood sugars: wk 52 | Feeling of unacceptably low blood sugars: wk 26 | Feeling of unacceptably low blood sugars: wk 52 | Convenience of treatment: wk 26 | Convenience of treatment: wk 52 | Flexibility of treatment: wk 26 | Flexibility of treatment: wk 52 | Satisfaction with understading of diabetes: wk 26 | Satisfaction with understading of diabetes: wk 52 | Recommending treatment to others: wk 26 | Recommending treatment to others: wk 52 | Satisfaction to continue present treatment: wk 26 | Satisfaction to continue present treatment: wk 52 | Total treatment satisfaction: wk 26 | Total treatmemt satisfaction: wk 52 | |
| Oral Semaglutide 14 mg | 0.63 | 0.78 | -1.29 | -1.34 | 0.13 | -0.06 | 0.50 | 0.44 | 0.40 | 0.46 | 0.27 | 0.34 | 0.53 | 0.65 | 0.58 | 0.65 | 2.90 | 3.32 |
| Oral Semaglutide 3 mg | 0.47 | 0.53 | -0.62 | -0.70 | 0.07 | 0.04 | 0.51 | 0.38 | 0.31 | 0.25 | 0.24 | 0.25 | 0.20 | 0.32 | 0.40 | 0.41 | 2.12 | 2.14 |
| Oral Semaglutide 7 mg | 0.59 | 0.51 | -1.23 | -1.15 | -0.06 | -0.10 | 0.50 | 0.52 | 0.37 | 0.42 | 0.31 | 0.35 | 0.66 | 0.63 | 0.57 | 0.56 | 3.00 | 2.99 |
| Placebo | 0.18 | 0.20 | -0.28 | -0.41 | -0.15 | -0.02 | 0.20 | 0.19 | 0.23 | 0.23 | 0.04 | 0.03 | 0.02 | -0.01 | 0.09 | 0.03 | 0.76 | 0.67 |
Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Participants (Count of Participants) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Normal (week 0) to Normal (week 26) | Normal (week 0) to Abnormal NCS (week 26) | Normal (week 0) to Abnormal CS (week 26) | Abnormal NCS (week 0) to Normal (week 26) | Abnormal NCS (week 0) to Abnormal NCS (week 26) | Abnormal NCS (week 0) to Abnormal CS (week 26) | Abnormal CS (week 0) to Normal (week 26) | Abnormal CS (week 0) to Abnormal NCS (week 26) | Abnormal CS (week 0) to Abnormal CS (week 26) | Normal (week 0) to Normal (week 52) | Normal (week 0) to Abnormal NCS (week 52) | Normal (week 0) to Abnormal CS (week 52) | Abnormal NCS to Normal (Week 52) | Abnormal NCS to Abnormal NCS (Week 52) | Abnormal NCS to Abnormal CS (Week 52) | Abnormal CS to Normal (Week 52) | Abnormal CS to Abnormal NCS (Week 52) | Abnormal CS to Abnormal CS (Week 52) | |
| Oral Semaglutide 14 mg | 90 | 17 | 0 | 16 | 47 | 0 | 1 | 1 | 1 | 85 | 20 | 1 | 19 | 42 | 0 | 0 | 2 | 1 |
| Oral Semaglutide 3 mg | 101 | 10 | 0 | 22 | 44 | 0 | 0 | 0 | 0 | 95 | 14 | 2 | 13 | 50 | 0 | 0 | 0 | 0 |
| Oral Semaglutide 7 mg | 98 | 12 | 0 | 17 | 42 | 0 | 0 | 0 | 4 | 91 | 15 | 2 | 17 | 40 | 1 | 0 | 0 | 4 |
| Placebo | 93 | 12 | 0 | 19 | 51 | 0 | 1 | 0 | 1 | 84 | 17 | 1 | 21 | 47 | 1 | 0 | 1 | 1 |
Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | mmol/L (Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | -1.36 | -1.60 |
| Oral Semaglutide 3 mg | -0.45 | -0.81 |
| Oral Semaglutide 7 mg | -1.14 | -1.12 |
| Placebo | 0.51 | -0.09 |
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26
| Intervention | Percentage of HbA1c (Mean) | |
|---|---|---|
| In-trial | On-treatment without rescue medication | |
| Oral Semaglutide 14 mg | -1.3 | -1.4 |
| Oral Semaglutide 3 mg | -0.5 | -0.6 |
| Oral Semaglutide 7 mg | -1.0 | -1.1 |
| Placebo | -0.1 | -0.1 |
Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Ratio of HDL cholesterol (Geometric Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | 0.98 | 1.01 |
| Oral Semaglutide 3 mg | 1.00 | 1.01 |
| Oral Semaglutide 7 mg | 0.98 | 0.98 |
| Placebo | 1.01 | 1.00 |
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Score on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1) Psychosocial (Week 26) | 1) Psychosocial (Week 52) | 2) Physical (Week 26) | 2) Physical (Week 52) | 3) Physical function(Week 26) | 3) Physical function(Week 52) | 4) Pain/discomfort (Week 26) | 4) Pain/discomfort (Week 52) | 5) IWQOL-Lite-CT Total (Week 26) | 5) IWQOL-Lite-CT Total (Week 52) | |
| Oral Semaglutide 14 mg | 4.10 | 5.35 | 2.15 | 2.50 | 2.51 | 2.59 | 1.23 | 2.28 | 3.41 | 4.35 |
| Oral Semaglutide 3 mg | 1.45 | 1.96 | 2.29 | 3.10 | 1.88 | 3.45 | 3.30 | 2.23 | 1.74 | 2.35 |
| Oral Semaglutide 7 mg | -0.32 | -0.92 | -0.66 | -0.53 | -0.35 | -0.59 | -1.45 | -0.37 | -0.45 | -0.79 |
| Placebo | -0.49 | -0.46 | -1.75 | -1.24 | -1.70 | -0.98 | -1.85 | -1.88 | -0.94 | -0.73 |
Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Ratio of LDL cholesterol (Geometric Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | 0.93 | 0.95 |
| Oral Semaglutide 3 mg | 0.98 | 0.97 |
| Oral Semaglutide 7 mg | 0.93 | 0.96 |
| Placebo | 1.03 | 1.00 |
Change from baseline (week 0) in lipase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Ratio of lipase (Geometric Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | 1.35 | 1.35 |
| Oral Semaglutide 3 mg | 1.14 | 1.09 |
| Oral Semaglutide 7 mg | 1.34 | 1.25 |
| Placebo | 0.99 | 0.99 |
Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Beats/minute (Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | 3 | 2 |
| Oral Semaglutide 3 mg | 1 | -0 |
| Oral Semaglutide 7 mg | 2 | 1 |
| Placebo | -0 | 0 |
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | mmHg (Mean) | |||
|---|---|---|---|---|
| SBP: Week 26 | SBP: Week 52 | DBP: Week 26 | DBP: Week 52 | |
| Oral Semaglutide 14 mg | -5 | -6 | -1 | -2 |
| Oral Semaglutide 3 mg | -1 | -1 | -0 | -1 |
| Oral Semaglutide 7 mg | -3 | -3 | -1 | -2 |
| Placebo | 1 | 0 | 0 | -0 |
Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | mmol/L (Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | -2.0 | -2.0 |
| Oral Semaglutide 3 mg | -1.2 | -1.6 |
| Oral Semaglutide 7 mg | -1.8 | -1.7 |
| Placebo | -0.3 | -0.9 |
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Score on a scale (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1) Physical functioning (Week 26) | 1) Physical functioning (Week 52) | 2) Role Physical (Week 26) | 2) Role Physical (Week 52) | 3) Bodily Pain (Week 26) | 3) Bodily Pain (Week 52) | 4) General Health (Week 26) | 4) General Health (Week 52) | 5) Vitality (Week 26) | 5) Vitality (Week 52) | 6) Social functioning (Week 26) | 6) Social functioning (Week 52) | 7) Role emotional (Week 26) | 7) Role emotional (Week 52) | 8) Mental health (Week 26) | 8) Mental health (Week 52) | 9) Physical component summary (Week 26) | 9) Physical component summary (Week 52) | 10) Mental component summary (Week 26) | 10) Mental component summary (Week 52) | |
| Oral Semaglutide 14 mg | -0.07 | -0.32 | 0.04 | -0.87 | -0.18 | -0.21 | 1.26 | 1.38 | 0.14 | 0.70 | -0.51 | 0.03 | 0.24 | 0.09 | 0.99 | 0.89 | -0.02 | -0.36 | 0.49 | 0.82 |
| Oral Semaglutide 3 mg | 0.53 | 0.51 | -0.32 | 0.00 | -0.02 | -0.40 | 1.43 | 0.92 | -0.56 | -0.53 | -0.31 | 0.11 | -0.94 | 0.77 | -1.41 | -0.48 | 0.94 | 0.26 | -1.41 | -0.09 |
| Oral Semaglutide 7 mg | 0.52 | -0.40 | -0.43 | -0.76 | 1.47 | 0.56 | 0.70 | 0.75 | -1.27 | -1.43 | 0.34 | -0.61 | 0.62 | -0.34 | -0.82 | -0.74 | 0.75 | 0.12 | -0.55 | -0.89 |
| Placebo | -0.82 | -0.77 | -0.39 | -0.93 | -0.72 | -0.64 | -0.36 | -1.43 | -1.69 | -1.09 | -1.10 | -1.74 | -1.50 | -2.78 | -2.32 | -1.30 | -0.05 | -0.41 | -2.16 | -2.19 |
Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | mmol/L (Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | -1.2 | -0.7 |
| Oral Semaglutide 3 mg | -0.3 | -0.3 |
| Oral Semaglutide 7 mg | -0.8 | -0.7 |
| Placebo | -0.1 | -0.3 |
Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Ratio of total cholesterol (Geometric Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | 0.95 | 0.95 |
| Oral Semaglutide 3 mg | 0.99 | 0.98 |
| Oral Semaglutide 7 mg | 0.95 | 0.97 |
| Placebo | 1.03 | 1.00 |
Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Units/day (Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | -8 | -5 |
| Oral Semaglutide 3 mg | -5 | 1 |
| Oral Semaglutide 7 mg | -9 | -8 |
| Placebo | -2 | 8 |
Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | Ratio of triglycerides (Geometric Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | 0.91 | 0.86 |
| Oral Semaglutide 3 mg | 0.97 | 0.93 |
| Oral Semaglutide 7 mg | 0.92 | 0.94 |
| Placebo | 0.99 | 0.97 |
Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 0, week 26, week 52
| Intervention | cm (Mean) | |
|---|---|---|
| Week 26 | Week 52 | |
| Oral Semaglutide 14 mg | -3.6 | -4.0 |
| Oral Semaglutide 3 mg | -0.9 | -0.8 |
| Oral Semaglutide 7 mg | -2.3 | -2.3 |
| Placebo | -0.6 | 0.3 |
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. (NCT03021187)
Timeframe: Weeks 0-52
| Intervention | nmol/L (Geometric Mean) | ||||
|---|---|---|---|---|---|
| Week 4 | Week 14 | Week 26 | Week 38 | Week 52 | |
| Oral Semaglutide 14 mg | 2.9 | 14.5 | 12.6 | 10.8 | 11.9 |
| Oral Semaglutide 3 mg | 2.9 | 2.9 | 2.7 | 2.5 | 2.4 |
| Oral Semaglutide 7 mg | 2.9 | 7.5 | 7.2 | 6.9 | 5.8 |
Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT03021187)
Timeframe: Weeks 0-52
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Week 0-26 | Week 0-52 | |
| Oral Semaglutide 14 mg | 8 | 44 |
| Oral Semaglutide 3 mg | 9 | 61 |
| Oral Semaglutide 7 mg | 8 | 45 |
| Placebo | 11 | 75 |
Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 1) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. (NCT03021187)
Timeframe: Weeks 0-52
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Week 0-26 | Week 0-52 | |
| Oral Semaglutide 14 mg | 4 | 31 |
| Oral Semaglutide 3 mg | 5 | 54 |
| Oral Semaglutide 7 mg | 2 | 33 |
| Placebo | 9 | 67 |
Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT03021187)
Timeframe: Week -2, week 52
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Left eye (week -2)72577392 | Left eye (week -2)72577393 | Left eye (week -2)72577394 | Left eye (week -2)72577395 | Left eye (week 52)72577392 | Left eye (week 52)72577393 | Left eye (week 52)72577394 | Left eye (week 52)72577395 | Right eye (week -2)72577392 | Right eye (week -2)72577393 | Right eye (week -2)72577394 | Right eye (week -2)72577395 | Right eye (week 52)72577392 | Right eye (week 52)72577393 | Right eye (week 52)72577394 | Right eye (week 52)72577395 | |||||||||||||||||||||||||||||||||
| Normal | Abnormal NCS | Abnormal CS | ||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 89 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 108 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 64 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 55 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 19 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 21 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 83 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 102 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 92 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 88 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 65 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 51 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 52 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 53 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 22 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 25 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 85 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 104 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 99 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 106 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 76 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 63 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 64 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 58 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 13 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 18 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 20 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 79 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 99 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 97 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 90 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 67 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 54 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 51 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 50 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 23 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 14 | |||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 15 | |||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 26 | |||||||||||||||||||||||||||||||||||||||||||||||
Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland. (NCT03021187)
Timeframe: Week -2, week 52
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1) Cardiovascular system (week -2)72577392 | 1) Cardiovascular system (week -2)72577393 | 1) Cardiovascular system (week -2)72577394 | 1) Cardiovascular system (week -2)72577395 | 1) Cardiovascular system (week 52)72577392 | 1) Cardiovascular system (week 52)72577393 | 1) Cardiovascular system (week 52)72577394 | 1) Cardiovascular system (week 52)72577395 | 2) Central and peripheral nervous system (week -2)72577392 | 2) Central and peripheral nervous system (week -2)72577395 | 2) Central and peripheral nervous system (week -2)72577393 | 2) Central and peripheral nervous system (week -2)72577394 | 2) Central and peripheral nervous system (week 52)72577392 | 2) Central and peripheral nervous system (week 52)72577393 | 2) Central and peripheral nervous system (week 52)72577394 | 2) Central and peripheral nervous system (week 52)72577395 | 3) Gastrointestinal system, incl. mouth (week -2)72577393 | 3) Gastrointestinal system, incl. mouth (week -2)72577395 | 3) Gastrointestinal system, incl. mouth (week -2)72577392 | 3) Gastrointestinal system, incl. mouth (week -2)72577394 | 3) Gastrointestinal system, incl. mouth (week 52)72577392 | 3) Gastrointestinal system, incl. mouth (week 52)72577393 | 3) Gastrointestinal system, incl. mouth (week 52)72577395 | 3) Gastrointestinal system, incl. mouth (week 52)72577394 | 4) General appearance (week -2)72577392 | 4) General appearance (week -2)72577393 | 4) General appearance (week -2)72577394 | 4) General appearance (week -2)72577395 | 4) General appearance (week 52)72577392 | 4) General appearance (week 52)72577393 | 4) General appearance (week 52)72577394 | 4) General appearance (week 52)72577395 | 5) Head, ears, eyes, nose, throat, neck (week -2)72577392 | 5) Head, ears, eyes, nose, throat, neck (week -2)72577393 | 5) Head, ears, eyes, nose, throat, neck (week -2)72577394 | 5) Head, ears, eyes, nose, throat, neck (week -2)72577395 | 5) Head, ears, eyes, nose, throat, neck (week 52)72577392 | 5) Head, ears, eyes, nose, throat, neck (week 52)72577393 | 5) Head, ears, eyes, nose, throat, neck (week 52)72577394 | 5) Head, ears, eyes, nose, throat, neck (week 52)72577395 | 6) Lymph node palpation (week -2)72577392 | 6) Lymph node palpation (week -2)72577393 | 6) Lymph node palpation (week -2)72577394 | 6) Lymph node palpation (week -2)72577395 | 6) Lymph node palpation (week 52)72577392 | 6) Lymph node palpation (week 52)72577393 | 6) Lymph node palpation (week 52)72577394 | 6) Lymph node palpation (week 52)72577395 | 7) Musculoskeletal system (week -2)72577392 | 7) Musculoskeletal system (week -2)72577393 | 7) Musculoskeletal system (week -2)72577395 | 7) Musculoskeletal system (week -2)72577394 | 7) Musculoskeletal system (week 52)72577392 | 7) Musculoskeletal system (week 52)72577393 | 7) Musculoskeletal system (week 52)72577394 | 7) Musculoskeletal system (week 52)72577395 | 8) Respiratory system (week -2)72577392 | 8) Respiratory system (week -2)72577393 | 8) Respiratory system (week -2)72577394 | 8) Respiratory system (week -2)72577395 | 8) Respiratory system (week 52)72577392 | 8) Respiratory system (week 52)72577393 | 8) Respiratory system (week 52)72577394 | 8) Respiratory system (week 52)72577395 | 9) Skin (week -2)72577392 | 9) Skin (week -2)72577393 | 9) Skin (week -2)72577394 | 9) Skin (week -2)72577395 | 9) Skin (week 52)72577392 | 9) Skin (week 52)72577393 | 9) Skin (week 52)72577394 | 9) Skin (week 52)72577395 | 10) Thyroid gland (week -2)72577393 | 10) Thyroid gland (week -2)72577392 | 10) Thyroid gland (week -2)72577394 | 10) Thyroid gland (week -2)72577395 | 10) Thyroid gland (week 52)72577393 | 10) Thyroid gland (week 52)72577392 | 10) Thyroid gland (week 52)72577394 | 10) Thyroid gland (week 52)72577395 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abnormal NCS | Normal | Abnormal CS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 166 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 166 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 157 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 170 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 14 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 157 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 158 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 145 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 160 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 158 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 157 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 158 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 163 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 149 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 150 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 147 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 25 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 175 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 177 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 180 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 163 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 166 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 171 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 159 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 162 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 160 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 151 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 148 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 153 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 152 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 23 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 168 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 173 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 172 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 178 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 161 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 165 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 166 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 184 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 181 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 181 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 172 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 172 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 171 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 170 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 169 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 175 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 160 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 160 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 164 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 182 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 177 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 180 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 184 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 173 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 164 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 170 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 173 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 156 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 153 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 159 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 162 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 27 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 28 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 152 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 144 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 151 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 155 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 26 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 177 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 176 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 176 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 177 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 7 mg | 165 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 14 mg | 168 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Oral Semaglutide 3 mg | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2672577393 | Week 2672577394 | Week 2672577395 | Week 2672577392 | Week 5272577392 | Week 5272577393 | Week 5272577395 | Week 5272577394 | |||||||||
| Yes | No | |||||||||||||||
| Oral Semaglutide 3 mg | 2 | |||||||||||||||
| Oral Semaglutide 7 mg | 12 | |||||||||||||||
| Oral Semaglutide 14 mg | 19 | |||||||||||||||
| Placebo | 1 | |||||||||||||||
| Oral Semaglutide 3 mg | 175 | |||||||||||||||
| Oral Semaglutide 7 mg | 162 | |||||||||||||||
| Oral Semaglutide 14 mg | 154 | |||||||||||||||
| Placebo | 176 | |||||||||||||||
| Oral Semaglutide 3 mg | 4 | |||||||||||||||
| Oral Semaglutide 7 mg | 17 | |||||||||||||||
| Oral Semaglutide 14 mg | 21 | |||||||||||||||
| Oral Semaglutide 3 mg | 170 | |||||||||||||||
| Oral Semaglutide 7 mg | 154 | |||||||||||||||
| Oral Semaglutide 14 mg | 149 | |||||||||||||||
| Placebo | 172 | |||||||||||||||
Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2672577392 | Week 2672577393 | Week 2672577394 | Week 2672577395 | Week 5272577395 | Week 5272577392 | Week 5272577393 | Week 5272577394 | |||||||||
| Yes | No | |||||||||||||||
| Oral Semaglutide 3 mg | 23 | |||||||||||||||
| Oral Semaglutide 7 mg | 53 | |||||||||||||||
| Placebo | 5 | |||||||||||||||
| Oral Semaglutide 3 mg | 154 | |||||||||||||||
| Oral Semaglutide 7 mg | 121 | |||||||||||||||
| Oral Semaglutide 14 mg | 106 | |||||||||||||||
| Placebo | 172 | |||||||||||||||
| Oral Semaglutide 3 mg | 30 | |||||||||||||||
| Oral Semaglutide 7 mg | 48 | |||||||||||||||
| Oral Semaglutide 14 mg | 67 | |||||||||||||||
| Placebo | 9 | |||||||||||||||
| Oral Semaglutide 3 mg | 144 | |||||||||||||||
| Oral Semaglutide 7 mg | 123 | |||||||||||||||
| Oral Semaglutide 14 mg | 103 | |||||||||||||||
| Placebo | 164 | |||||||||||||||
Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT03021187)
Timeframe: Week 26, week 52
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2672577392 | Week 2672577394 | Week 2672577393 | Week 2672577395 | Week 5272577392 | Week 5272577393 | Week 5272577394 | Week 5272577395 | |||||||||
| Yes | No | |||||||||||||||
| Oral Semaglutide 3 mg | 32 | |||||||||||||||
| Oral Semaglutide 7 mg | 47 | |||||||||||||||
| Oral Semaglutide 14 mg | 76 | |||||||||||||||
| Placebo | 4 | |||||||||||||||
| Oral Semaglutide 3 mg | 144 | |||||||||||||||
| Oral Semaglutide 7 mg | 127 | |||||||||||||||
| Oral Semaglutide 14 mg | 97 | |||||||||||||||
| Placebo | 172 | |||||||||||||||
| Oral Semaglutide 3 mg | 27 | |||||||||||||||
| Oral Semaglutide 7 mg | 43 | |||||||||||||||
| Oral Semaglutide 14 mg | 61 | |||||||||||||||
| Placebo | 8 | |||||||||||||||
| Oral Semaglutide 3 mg | 146 | |||||||||||||||
| Oral Semaglutide 7 mg | 126 | |||||||||||||||
| Oral Semaglutide 14 mg | 107 | |||||||||||||||
| Placebo | 164 | |||||||||||||||
Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. (NCT03021187)
Timeframe: Week 26, week 52
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2672577392 | Week 2672577395 | Week 2672577393 | Week 2672577394 | Week 5272577395 | Week 5272577392 | Week 5272577393 | Week 5272577394 | |||||||||
| Yes | No | |||||||||||||||
| Oral Semaglutide 3 mg | 28 | |||||||||||||||
| Oral Semaglutide 7 mg | 51 | |||||||||||||||
| Oral Semaglutide 14 mg | 76 | |||||||||||||||
| Placebo | 7 | |||||||||||||||
| Oral Semaglutide 3 mg | 148 | |||||||||||||||
| Oral Semaglutide 7 mg | 123 | |||||||||||||||
| Oral Semaglutide 14 mg | 97 | |||||||||||||||
| Placebo | 169 | |||||||||||||||
| Oral Semaglutide 3 mg | 20 | |||||||||||||||
| Oral Semaglutide 7 mg | 37 | |||||||||||||||
| Oral Semaglutide 14 mg | 64 | |||||||||||||||
| Placebo | 5 | |||||||||||||||
| Oral Semaglutide 3 mg | 153 | |||||||||||||||
| Oral Semaglutide 7 mg | 132 | |||||||||||||||
| Oral Semaglutide 14 mg | 104 | |||||||||||||||
| Placebo | 167 | |||||||||||||||
Number of particpants achieving HbA1c < 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2672577394 | Week 2672577395 | Week 2672577392 | Week 2672577393 | Week 5272577392 | Week 5272577393 | Week 5272577394 | Week 5272577395 | |||||||||
| No | Yes | |||||||||||||||
| Oral Semaglutide 7 mg | 74 | |||||||||||||||
| Oral Semaglutide 14 mg | 101 | |||||||||||||||
| Placebo | 12 | |||||||||||||||
| Oral Semaglutide 3 mg | 126 | |||||||||||||||
| Oral Semaglutide 7 mg | 100 | |||||||||||||||
| Oral Semaglutide 14 mg | 72 | |||||||||||||||
| Placebo | 164 | |||||||||||||||
| Oral Semaglutide 3 mg | 50 | |||||||||||||||
| Oral Semaglutide 7 mg | 67 | |||||||||||||||
| Oral Semaglutide 14 mg | 91 | |||||||||||||||
| Placebo | 16 | |||||||||||||||
| Oral Semaglutide 3 mg | 123 | |||||||||||||||
| Oral Semaglutide 7 mg | 102 | |||||||||||||||
| Oral Semaglutide 14 mg | 77 | |||||||||||||||
| Placebo | 156 | |||||||||||||||
Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. (NCT03021187)
Timeframe: Week 26, week 52
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2672577393 | Week 2672577394 | Week 2672577395 | Week 2672577392 | Week 5272577392 | Week 5272577394 | Week 5272577395 | Week 5272577393 | |||||||||
| Yes | No | |||||||||||||||
| Oral Semaglutide 3 mg | 24 | |||||||||||||||
| Oral Semaglutide 7 mg | 45 | |||||||||||||||
| Oral Semaglutide 14 mg | 74 | |||||||||||||||
| Placebo | 6 | |||||||||||||||
| Oral Semaglutide 3 mg | 152 | |||||||||||||||
| Oral Semaglutide 7 mg | 129 | |||||||||||||||
| Oral Semaglutide 14 mg | 99 | |||||||||||||||
| Placebo | 170 | |||||||||||||||
| Oral Semaglutide 3 mg | 20 | |||||||||||||||
| Oral Semaglutide 7 mg | 33 | |||||||||||||||
| Oral Semaglutide 14 mg | 65 | |||||||||||||||
| Placebo | 4 | |||||||||||||||
| Oral Semaglutide 3 mg | 153 | |||||||||||||||
| Oral Semaglutide 7 mg | 136 | |||||||||||||||
| Oral Semaglutide 14 mg | 103 | |||||||||||||||
| Placebo | 168 | |||||||||||||||
Determine if metformin treatment augments strength gains in conjunction with progressive resistance training by one repetition maximum assessments. Maximum (1RM) leg extension muscle strength was assessed at week 4 (to account for neurological adaptations during the initial stages of the resistance program) and week 16. The percent change from week 4 to week 16 is reported. (NCT02308228)
Timeframe: Week 4 and week 16
| Intervention | Percent change (Mean) |
|---|---|
| Metformin | 15.3 |
| Placebo, Sugar Pill | 23.1 |
The ability of metformin to improve the hypertrophic response at the whole muscle level will be quantified by computed tomography. Percent change in normal density muscle area will be calculated as the difference between week 16 and week 0. (NCT02308228)
Timeframe: 16 weeks
| Intervention | Percent change (Mean) |
|---|---|
| Metformin | 4.2 |
| Placebo, Sugar Pill | 10.5 |
To determine if metformin improves changes in body composition associated with progressive resistance training. Percent change in total body lean mass in kg was calculated as the difference between week 16 and week 0 from a total body DXA scan. (NCT02308228)
Timeframe: 16 weeks
| Intervention | Percent change (Mean) |
|---|---|
| Metformin | 0.41 |
| Placebo, Sugar Pill | 1.95 |
The ability of metformin to improve the hypertrophic response to resistance training will be determined. Muscle biopsies of the vastus lateralis will be used to quantify myofiber cross-sectional area. The percent change in type 2 myofiber size between week 16 and week 0 was used. (NCT02308228)
Timeframe: 16 weeks
| Intervention | Percent change (Mean) |
|---|---|
| Metformin | 18.5 |
| Placebo, Sugar Pill | 14.5 |
"Body weight change from baseline after 24 weeks.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication." (NCT01159600)
Timeframe: Baseline and 24 weeks
| Intervention | kg (Mean) |
|---|---|
| Met: Placebo | -0.45 |
| Met: Empa 10mg | -2.08 |
| Met: Empa 25mg | -2.46 |
| Met: Empa 25mg Open Label | -1.33 |
| Met+SU: Placebo | -0.39 |
| Met+SU: Empa 10mg | -2.16 |
| Met+SU: Empa 25mg | -2.39 |
| Met+SU: Empa 25mg Open Label | -1.29 |
Number of patients with confirmed hypoglycaemic events, as reported as adverse events. (NCT01159600)
Timeframe: From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
| Intervention | percentage of participants (Number) |
|---|---|
| Met: Placebo | 0.5 |
| Met: Empa 10mg | 1.8 |
| Met: Empa 25mg | 1.4 |
| Met: Empa 25mg Open Label | 2.9 |
| Met+SU: Placebo | 8.4 |
| Met+SU: Empa 10mg | 16.1 |
| Met+SU: Empa 25mg | 11.5 |
| Met+SU: Empa 25mg Open Label | 6.9 |
"Change from baseline in HbA1c after 24 weeks.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication." (NCT01159600)
Timeframe: Baseline and 24 weeks
| Intervention | percentage of HbA1c (Mean) |
|---|---|
| Met: Placebo | -0.13 |
| Met: Empa 10mg | -0.70 |
| Met: Empa 25mg | -0.77 |
| Met: Empa 25mg Open Label | -2.78 |
| Met+SU: Placebo | -0.17 |
| Met+SU: Empa 10mg | -0.82 |
| Met+SU: Empa 25mg | -0.77 |
| Met+SU: Empa 25mg Open Label | -2.53 |
"Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication." (NCT01159600)
Timeframe: Baseline and 24 weeks
| Intervention | mg/dL (Mean) |
|---|---|
| Met: Placebo | -1.99 |
| Met: Empa 10mg | -9.64 |
| Met: Empa 25mg | -14.36 |
| Met: Empa 25mg Open Label | -35.47 |
| Met+SU: Placebo | 0.00 |
| Met+SU: Empa 10mg | -10.01 |
| Met+SU: Empa 25mg | -13.06 |
| Met+SU: Empa 25mg Open Label | -29.34 |
Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment (NCT01289990)
Timeframe: Baseline and 52 weeks
| Intervention | kg (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -2.70 |
| BI 10773 High (Drug Naive) | -2.61 |
| Placebo (Drug Naive) | -0.48 |
| Sitagliptin 100mg (Drug Naive) | 0.14 |
| BI 10773 Low (Pioglitazone) | -1.50 |
| BI 10773 High (Pioglitazone) | -1.40 |
| Placebo (Pioglitazone) | 0.59 |
| BI 10773 Low (Metformin) | -2.27 |
| BI 10773 High (Metformin) | -2.84 |
| Placebo (Metformin) | -0.54 |
| BI 10773 Low (Metformin+Sulfonylurea) | -2.28 |
| BI 10773 High (Metformin+Sulfonylurea) | -2.32 |
| Placebo (Metformin+Sulfonylurea) | -0.31 |
Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment (NCT01289990)
Timeframe: Baseline and 76 weeks
| Intervention | kg (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -2.24 |
| BI 10773 High (Drug Naive) | -2.45 |
| Placebo (Drug Naive) | -0.43 |
| Sitagliptin 100mg (Drug Naive) | 0.10 |
| BI 10773 Low (Pioglitazone) | -1.47 |
| BI 10773 High (Pioglitazone) | -1.21 |
| Placebo (Pioglitazone) | 0.50 |
| BI 10773 Low (Metformin) | -2.39 |
| BI 10773 High (Metformin) | -2.65 |
| Placebo (Metformin) | -0.46 |
| BI 10773 Low (Metformin+Sulfonylurea) | -2.44 |
| BI 10773 High (Metformin+Sulfonylurea) | -2.28 |
| Placebo (Metformin+Sulfonylurea) | -0.63 |
Change from baseline in HbA1c after 52 weeks (NCT01289990)
Timeframe: Baseline and 52 weeks
| Intervention | % of HbA1c (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -0.70 |
| BI 10773 High (Drug Naive) | -0.82 |
| Placebo (Drug Naive) | 0.09 |
| Sitagliptin 100mg (Drug Naive) | -0.58 |
| BI 10773 Low (Pioglitazone) | -0.63 |
| BI 10773 High (Pioglitazone) | -0.71 |
| Placebo (Pioglitazone) | -0.03 |
| BI 10773 Low (Metformin) | -0.69 |
| BI 10773 High (Metformin) | -0.76 |
| Placebo (Metformin) | -0.07 |
| BI 10773 Low (Metformin+Sulfonylurea) | -0.78 |
| BI 10773 High (Metformin+Sulfonylurea) | -0.74 |
| Placebo (Metformin+Sulfonylurea) | -0.04 |
Change from baseline in HbA1c after 76 weeks (NCT01289990)
Timeframe: Baseline and 76 weeks
| Intervention | % of HbA1c (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -0.65 |
| BI 10773 High (Drug Naive) | -0.76 |
| Placebo (Drug Naive) | 0.13 |
| Sitagliptin 100mg (Drug Naive) | -0.53 |
| BI 10773 Low (Pioglitazone) | -0.61 |
| BI 10773 High (Pioglitazone) | -0.70 |
| Placebo (Pioglitazone) | -0.01 |
| BI 10773 Low (Metformin) | -0.62 |
| BI 10773 High (Metformin) | -0.74 |
| Placebo (Metformin) | -0.01 |
| BI 10773 Low (Metformin+Sulfonylurea) | -0.74 |
| BI 10773 High (Metformin+Sulfonylurea) | -0.72 |
| Placebo (Metformin+Sulfonylurea) | -0.03 |
Diastolic blood pressure - change from baseline after 52 weeks of treatment (NCT01289990)
Timeframe: Baseline and 52 weeks
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -1.3 |
| BI 10773 High (Drug Naive) | -1.9 |
| Placebo (Drug Naive) | -0.2 |
| Sitagliptin 100mg (Drug Naive) | -0.3 |
| BI 10773 Low (Pioglitazone) | -1.6 |
| BI 10773 High (Pioglitazone) | -2.2 |
| Placebo (Pioglitazone) | 0.4 |
| BI 10773 Low (Metformin) | -2.2 |
| BI 10773 High (Metformin) | -2.1 |
| Placebo (Metformin) | -0.4 |
| BI 10773 Low (Metformin+Sulfonylurea) | -1.7 |
| BI 10773 High (Metformin+Sulfonylurea) | -1.6 |
| Placebo (Metformin+Sulfonylurea) | -1.0 |
Diastolic blood pressure - change from baseline after 76 weeks of treatment (NCT01289990)
Timeframe: Baseline and 76 weeks
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -1.6 |
| BI 10773 High (Drug Naive) | -1.6 |
| Placebo (Drug Naive) | -0.6 |
| Sitagliptin 100mg (Drug Naive) | -0.1 |
| BI 10773 Low (Pioglitazone) | -1.3 |
| BI 10773 High (Pioglitazone) | -2.0 |
| Placebo (Pioglitazone) | 0.2 |
| BI 10773 Low (Metformin) | -2.5 |
| BI 10773 High (Metformin) | -1.9 |
| Placebo (Metformin) | -0.5 |
| BI 10773 Low (Metformin+Sulfonylurea) | -2.6 |
| BI 10773 High (Metformin+Sulfonylurea) | -2.3 |
| Placebo (Metformin+Sulfonylurea) | -1.4 |
Fasting plasma glucose - change from baseline after 52 weeks of treatment (NCT01289990)
Timeframe: Baseline and 52 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -18.9 |
| BI 10773 High (Drug Naive) | -23.9 |
| Placebo (Drug Naive) | 13.3 |
| Sitagliptin 100mg (Drug Naive) | -3.9 |
| BI 10773 Low (Pioglitazone) | -16.7 |
| BI 10773 High (Pioglitazone) | -20.7 |
| Placebo (Pioglitazone) | 10.3 |
| BI 10773 Low (Metformin) | -16.7 |
| BI 10773 High (Metformin) | -19.7 |
| Placebo (Metformin) | 7.6 |
| BI 10773 Low (Metformin+Sulfonylurea) | -18.4 |
| BI 10773 High (Metformin+Sulfonylurea) | -19.3 |
| Placebo (Metformin+Sulfonylurea) | 9.4 |
Fasting plasma glucose - change from baseline after 76 weeks of treatment (NCT01289990)
Timeframe: Baseline and 76 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -17.2 |
| BI 10773 High (Drug Naive) | -20.4 |
| Placebo (Drug Naive) | 14.4 |
| Sitagliptin 100mg (Drug Naive) | -1.8 |
| BI 10773 Low (Pioglitazone) | -13.9 |
| BI 10773 High (Pioglitazone) | -18.0 |
| Placebo (Pioglitazone) | 9.4 |
| BI 10773 Low (Metformin) | -14.5 |
| BI 10773 High (Metformin) | -20.9 |
| Placebo (Metformin) | 10.5 |
| BI 10773 Low (Metformin+Sulfonylurea) | -19.5 |
| BI 10773 High (Metformin+Sulfonylurea) | -20.4 |
| Placebo (Metformin+Sulfonylurea) | 11.4 |
Change from baseline in HbA1c (%) after 76 weeks using MMRM approach (NCT01289990)
Timeframe: Baseline and 76 weeks
| Intervention | % of HbA1c (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -0.70 |
| BI 10773 High (Drug Naive) | -0.77 |
| Placebo (Drug Naive) | 0.13 |
| Sitagliptin 100mg (Drug Naive) | -0.48 |
| BI 10773 Low (Pioglitazone) | -0.67 |
| BI 10773 High (Pioglitazone) | -0.77 |
| Placebo (Pioglitazone) | -0.05 |
| BI 10773 Low (Metformin) | -0.60 |
| BI 10773 High (Metformin) | -0.76 |
| Placebo (Metformin) | 0.07 |
| BI 10773 Low (Metformin+Sulfonylurea) | -0.75 |
| BI 10773 High (Metformin+Sulfonylurea) | -0.75 |
| Placebo (Metformin+Sulfonylurea) | 0.06 |
Systolic blood pressure - change from baseline after 52 weeks of treatment (NCT01289990)
Timeframe: Baseline and 52 weeks
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -4.9 |
| BI 10773 High (Drug Naive) | -4.5 |
| Placebo (Drug Naive) | -1.6 |
| Sitagliptin 100mg (Drug Naive) | -0.2 |
| BI 10773 Low (Pioglitazone) | -1.8 |
| BI 10773 High (Pioglitazone) | -3.3 |
| Placebo (Pioglitazone) | 0.6 |
| BI 10773 Low (Metformin) | -3.6 |
| BI 10773 High (Metformin) | -5.2 |
| Placebo (Metformin) | -0.7 |
| BI 10773 Low (Metformin+Sulfonylurea) | -3.1 |
| BI 10773 High (Metformin+Sulfonylurea) | -2.7 |
| Placebo (Metformin+Sulfonylurea) | -0.2 |
Systolic blood pressure - change from baseline after 76 weeks of treatment (NCT01289990)
Timeframe: Baseline and 76 weeks
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -4.1 |
| BI 10773 High (Drug Naive) | -4.2 |
| Placebo (Drug Naive) | -0.7 |
| Sitagliptin 100mg (Drug Naive) | -0.3 |
| BI 10773 Low (Pioglitazone) | -1.7 |
| BI 10773 High (Pioglitazone) | -3.4 |
| Placebo (Pioglitazone) | 0.3 |
| BI 10773 Low (Metformin) | -5.2 |
| BI 10773 High (Metformin) | -4.5 |
| Placebo (Metformin) | -0.8 |
| BI 10773 Low (Metformin+Sulfonylurea) | -3.8 |
| BI 10773 High (Metformin+Sulfonylurea) | -3.7 |
| Placebo (Metformin+Sulfonylurea) | -1.6 |
Waist circumference (cm) - change from baseline after 52 weeks of treatment (NCT01289990)
Timeframe: Baseline and 52 weeks
| Intervention | cm (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -2.0 |
| BI 10773 High (Drug Naive) | -1.7 |
| Placebo (Drug Naive) | 0.1 |
| Sitagliptin 100mg (Drug Naive) | 0.4 |
| BI 10773 Low (Pioglitazone) | -1.5 |
| BI 10773 High (Pioglitazone) | -1.1 |
| Placebo (Pioglitazone) | -0.1 |
| BI 10773 Low (Metformin) | -1.5 |
| BI 10773 High (Metformin) | -2.0 |
| Placebo (Metformin) | -0.4 |
| BI 10773 Low (Metformin+Sulfonylurea) | -1.5 |
| BI 10773 High (Metformin+Sulfonylurea) | -1.5 |
| Placebo (Metformin+Sulfonylurea) | -0.2 |
Waist circumference (cm) - change from baseline after 76 weeks of treatment (NCT01289990)
Timeframe: Baseline and 76 weeks
| Intervention | cm (Least Squares Mean) |
|---|---|
| BI 10773 Low (Drug Naive) | -1.5 |
| BI 10773 High (Drug Naive) | -1.6 |
| Placebo (Drug Naive) | 0.1 |
| Sitagliptin 100mg (Drug Naive) | 0.5 |
| BI 10773 Low (Pioglitazone) | -1.4 |
| BI 10773 High (Pioglitazone) | -0.9 |
| Placebo (Pioglitazone) | 0.0 |
| BI 10773 Low (Metformin) | -1.8 |
| BI 10773 High (Metformin) | -1.3 |
| Placebo (Metformin) | -0.2 |
| BI 10773 Low (Metformin+Sulfonylurea) | -1.6 |
| BI 10773 High (Metformin+Sulfonylurea) | -1.4 |
| Placebo (Metformin+Sulfonylurea) | -0.3 |
Percent of dose recovered in urine as unchanged drug. Ae24% = 100* Ae24/Dose (NCT03538743)
Timeframe: 0 to 24 hours post-dose on Day 28
| Intervention | Percentage (Geometric Mean) |
|---|---|
| PF-06882961 15mg BID (Cohort 1) | 0.05747 |
| PF-06882961 50mg BID (Cohort 2) | 0.03360 |
| PF-06882961 70mg BID (Cohort 3) | 0.02942 |
| PF-06882961 120mg BID (Cohort 4) | NA |
| PF-06882961 10mg BID (Cohort 5) | 0.07483 |
| PF-06882961 120mg BID ST (Cohort 6) | 0.02607 |
| PF-06882961 200mg QD CR (Cohort 7) | 0.03652 |
| PF-06882961 120mg QD (Cohort 8) | 0.04094 |
Ae was the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval was 24 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL was the approximate specific gravity of urine. (NCT03538743)
Timeframe: 0 to 24 hours post-dose on Day 28
| Intervention | microgram (Geometric Mean) |
|---|---|
| PF-06882961 15mg BID (Cohort 1) | 17.25 |
| PF-06882961 50mg BID (Cohort 2) | 33.60 |
| PF-06882961 70mg BID (Cohort 3) | 41.16 |
| PF-06882961 120mg BID (Cohort 4) | NA |
| PF-06882961 10mg BID (Cohort 5) | 14.97 |
| PF-06882961 120mg BID ST (Cohort 6) | 62.63 |
| PF-06882961 200mg QD CR (Cohort 7) | 72.98 |
| PF-06882961 120mg QD (Cohort 8) | 49.09 |
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin). (NCT03538743)
Timeframe: From baseline to up to 14 days after last dose for a total of approximately 42 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 24 |
| PF-06882961 10mg BID | 7 |
| PF-06882961 15mg BID | 8 |
| PF-06882961 50mg BID | 10 |
| PF-06882961 70mg BID | 8 |
| PF-06882961 120mg BID | 8 |
| PF-06882961 120mg BID ST | 9 |
| PF-06882961 120mg QD | 7 |
| PF-06882961 200mg QD CR | 10 |
CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours. (NCT03538743)
Timeframe: 0 to 24 hours post-dose on Day 28
| Intervention | mL/min (Geometric Mean) |
|---|---|
| PF-06882961 15mg BID (Cohort 1) | 0.3273 |
| PF-06882961 50mg BID (Cohort 2) | 0.3385 |
| PF-06882961 70mg BID (Cohort 3) | 0.3094 |
| PF-06882961 120mg BID (Cohort 4) | NA |
| PF-06882961 10mg BID (Cohort 5) | 0.5470 |
| PF-06882961 120mg BID ST (Cohort 6) | 0.2006 |
| PF-06882961 200mg QD CR (Cohort 7) | 0.2895 |
| PF-06882961 120mg QD (Cohort 8) | 0.3178 |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT03538743)
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28
| Intervention | hours (Mean) |
|---|---|
| PF-06882961 15mg BID (Cohort 1) | 5.100 |
| PF-06882961 50mg BID (Cohort 2) | 5.067 |
| PF-06882961 70mg BID (Cohort 3) | 4.681 |
| PF-06882961 120mg BID (Cohort 4) | 6.203 |
| PF-06882961 10mg BID (Cohort 5) | 8.090 |
| PF-06882961 120mg BID ST (Cohort 6) | 6.730 |
| PF-06882961 200mg QD CR (Cohort 7) | 5.773 |
| PF-06882961 120mg QD (Cohort 8) | 4.954 |
Area under the concentration-time profile from time zero to time 24 hours (AUC24) was calculated as AUCtau1 +AUCtau2, where AUCtau was area under the plasma concentration-time profile from time zero to time tau (tau1 = 0 to 10 hours and tau2=10 to 24 hours). AUCtau was determined using linear/log trapezoidal method. (NCT03538743)
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
| Intervention | nanogram.hours/milliliter (ng.h/mL) (Geometric Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| AUC24 on Day 1 | AUCtau1 on Day 1 | AUCtau2 on Day 1 | AUC24 on Day 14 or 21 | AUCtau1 on Day 14 or 21 | AUCtau2 on Day 14 or 21 | AUC24 on Day 28 | AUCtau1 on Day 28 | AUCtau2 on Day 28 | |
| PF-06882961 10mg BID (Cohort 5) | 178.7 | 74.50 | 103.7 | 201.6 | 85.57 | 115.4 | 455.9 | 190.8 | 261.0 |
| PF-06882961 120mg BID (Cohort 4) | 666.1 | 260.3 | 401.9 | 8149 | 3772 | 4361 | 8368 | 3534 | 4852 |
| PF-06882961 120mg BID ST (Cohort 6) | 324.0 | 147.7 | 176.4 | 2660 | 957.3 | 1693 | 5973 | 2249 | 3668 |
| PF-06882961 120mg QD (Cohort 8) | 184.6 | NA | NA | 1204 | NA | NA | 2723 | NA | NA |
| PF-06882961 15mg BID (Cohort 1) | 707.5 | 288.1 | 414.8 | 853.8 | 348.6 | 500.1 | 876.7 | 331.1 | 534.7 |
| PF-06882961 200mg QD CR (Cohort 7) | 393.9 | NA | NA | 1291 | NA | NA | 4372 | NA | NA |
| PF-06882961 50mg BID (Cohort 2) | 1502 | 741.4 | 678.5 | 2092 | 880.3 | 1175 | 1653 | 671.1 | 960.1 |
| PF-06882961 70mg BID (Cohort 3) | 645.8 | 279.7 | 364.9 | 2988 | 1462 | 1517 | 3171 | 1153 | 1970 |
"For BID dosing, parameters were calculated for both dosing intervals (0-10 hr = interval 1 and 10-24 hr = interval 2) and were displayed as Cmax1, Cmax2.~Cmax1: maximum plasma concentration during the dosing interval τ1 =0 to 10 hours.~Cmax2: maximum plasma concentration during the dosing interval τ2=10 to 24 hours." (NCT03538743)
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28
| Intervention | nanogram/milliliter (ng/mL) (Geometric Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Cmax on Day 1 | Cmax1 on Day 1 | Cmax2 on Day 1 | Cmax on Day 14 or 21 | Cmax1 on Day 14 or 21 | Cmax2 on Day 14 or 21 | Cmax on Day 28 | Cmax1 on Day 28 | Cmax2 on Day 28 | |
| PF-06882961 10mg BID (Cohort 5) | 15.02 | 12.82 | 13.98 | 18.63 | 15.31 | 17.16 | 38.38 | 30.42 | 35.01 |
| PF-06882961 120mg BID (Cohort 4) | 51.61 | 36.51 | 44.97 | 788.4 | 682.7 | 505.3 | 685.2 | 649.2 | 617.9 |
| PF-06882961 120mg BID ST (Cohort 6) | 26.02 | 24.06 | 21.64 | 188.5 | 143.0 | 178.4 | 437.6 | 357.1 | 410.3 |
| PF-06882961 120mg QD (Cohort 8) | 20.40 | NA | NA | 100.7 | NA | NA | 192.2 | NA | NA |
| PF-06882961 15mg BID (Cohort 1) | 50.58 | 42.69 | 40.63 | 65.78 | 55.00 | 63.89 | 81.56 | 50.24 | 74.22 |
| PF-06882961 200mg QD CR (Cohort 7) | 28.67 | NA | NA | 98.11 | NA | NA | 303.9 | NA | NA |
| PF-06882961 50mg BID (Cohort 2) | 124.4 | 119.1 | 68.77 | 149.8 | 130.2 | 127.9 | 133.7 | 103.8 | 117.2 |
| PF-06882961 70mg BID (Cohort 3) | 49.75 | 45.01 | 42.33 | 253.6 | 235.1 | 202.8 | 328.8 | 197.9 | 306.5 |
"ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec.~2. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline.~3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline" (NCT03538743)
Timeframe: From baseline to up to 14 days after last dose for a total of approximately 42 days
| Intervention | Participants (Count of Participants) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| PR interval ≥300 msec | %Change in PR interval ≥25/50% | QRS duration ≥140 msec | %Change in QRS duration ≥50% | QTcF interval >450 and ≤480 msec | QTcF interval >480 and ≤500 msec | QTcF interval >500 msec | Change in QTcF interval >30 and ≤60 msec | Change in QTcF interval >60 msec | |
| PF-06882961 10mg BID | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| PF-06882961 120mg BID | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| PF-06882961 120mg BID ST | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PF-06882961 120mg QD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PF-06882961 15mg BID | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| PF-06882961 200mg QD CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PF-06882961 50mg BID | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PF-06882961 70mg BID | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Placebo | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >= 20 mmHg. (NCT03538743)
Timeframe: From baseline to up to 14 days after last dose for a total of approximately 42 days
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| Supine SBP <90 mmHg | Supine SBP increase >=30 mmHg | Supine SBP decrease >=30 mmHg | Supine DBP <50 mmHg | Supine DBP increase >=20 mmHg | Supine DBP decrease >=20 mmHg | Supine pulse rate <40 bpm | Supine pulse rate >120 bpm | |
| PF-06882961 10mg BID | 3 | 0 | 2 | 1 | 1 | 2 | 0 | 0 |
| PF-06882961 120mg BID | 0 | 1 | 3 | 0 | 1 | 3 | 0 | 0 |
| PF-06882961 120mg BID ST | 3 | 2 | 3 | 2 | 2 | 4 | 0 | 0 |
| PF-06882961 120mg QD | 0 | 2 | 5 | 0 | 2 | 2 | 0 | 0 |
| PF-06882961 15mg BID | 2 | 0 | 5 | 2 | 1 | 1 | 0 | 0 |
| PF-06882961 200mg QD CR | 1 | 1 | 4 | 0 | 1 | 3 | 0 | 0 |
| PF-06882961 50mg BID | 1 | 2 | 3 | 1 | 0 | 2 | 0 | 0 |
| PF-06882961 70mg BID | 3 | 3 | 5 | 1 | 4 | 1 | 0 | 0 |
| Placebo | 3 | 4 | 9 | 1 | 1 | 6 | 0 | 0 |
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent. (NCT03538743)
Timeframe: From baseline to up to 35 days after last dose for a total of approximately 63 days
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| All-causality AE | All-causality SAE | Treatment-related AE | Treatment-related SAE | |
| PF-06882961 10mg BID | 6 | 0 | 4 | 0 |
| PF-06882961 120mg BID | 8 | 0 | 8 | 0 |
| PF-06882961 120mg BID ST | 9 | 1 | 9 | 0 |
| PF-06882961 120mg QD | 8 | 0 | 8 | 0 |
| PF-06882961 15mg BID | 8 | 0 | 4 | 0 |
| PF-06882961 200mg QD CR | 9 | 0 | 9 | 0 |
| PF-06882961 50mg BID | 10 | 0 | 10 | 0 |
| PF-06882961 70mg BID | 8 | 0 | 7 | 0 |
| Placebo | 17 | 0 | 14 | 0 |
Time for Cmax, Cmax1 and Cmax2 (Tmax, Tmax1 and Tmax2) of PF-06293620 was observed directly from data as time of first occurrence. (NCT03538743)
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
| Intervention | hours (Median) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Tmax on Day 1 | Tmax1 on Day 1 | Tmax2 on Day 1 | Tmax on Day 14 or 21 | Tmax1 on Day 14 or 21 | Tmax2 on Day 14 or 21 | Tmax on Day 28 | Tmax1 on Day 28 | Tmax2 on Day 28 | |
| PF-06882961 10mg BID (Cohort 5) | NA | 2.00 | 12.0 | NA | 6.00 | 12.0 | NA | 4.00 | 12.0 |
| PF-06882961 120mg BID (Cohort 4) | NA | 4.00 | 14.0 | NA | 1.54 | 12.0 | NA | 4.00 | 12.0 |
| PF-06882961 120mg BID ST (Cohort 6) | NA | 2.00 | 14.0 | NA | 6.00 | 14.0 | NA | 6.00 | 12.0 |
| PF-06882961 120mg QD (Cohort 8) | 3.00 | NA | NA | 6.00 | NA | NA | 10.0 | NA | NA |
| PF-06882961 15mg BID (Cohort 1) | NA | 4.00 | 14.0 | NA | 4.00 | 13.0 | NA | 5.00 | 12.0 |
| PF-06882961 200mg QD CR (Cohort 7) | 13.0 | NA | NA | 12.0 | NA | NA | 14.0 | NA | NA |
| PF-06882961 50mg BID (Cohort 2) | NA | 4.00 | 14.0 | NA | 4.00 | 13.0 | NA | 3.00 | 12.0 |
| PF-06882961 70mg BID (Cohort 3) | NA | 2.00 | 14.0 | NA | 1.05 | 12.0 | NA | 6.00 | 12.0 |
LS means of the body weight change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline body weight as covariate, via a MMRM analysis. (NCT02152371)
Timeframe: Baseline, 28 Weeks
| Intervention | kilogram(kg) (Least Squares Mean) |
|---|---|
| Dulaglutide + Insulin Glargine | -1.91 |
| Placebo + Insulin Glargine | 0.50 |
Least Square (LS) Means of the insulin dose change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline insulin dose as covariate, via a MMRM analysis. (NCT02152371)
Timeframe: Baseline, 28 Weeks
| Intervention | units (u) (Least Squares Mean) |
|---|---|
| Dulaglutide + Insulin Glargine | 12.75 |
| Placebo + Insulin Glargine | 25.94 |
FSG is a test to determine glucose levels after an overnight fast. LS means FSG change from baseline to primary endpoint at week 28 was calculated using a mixed effects model for repeated measures (MMRM) analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline FSG as covariate. (NCT02152371)
Timeframe: Baseline, 28 Weeks
| Intervention | milligram per deciliter (mg/dL) (Least Squares Mean) |
|---|---|
| Dulaglutide + Insulin Glargine | -44.63 |
| Placebo + Insulin Glargine | -27.90 |
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least-squares (LS) mean and standard error (SE) changes from baseline in HbA1c at 28 weeks were measured using mixed model regression and restricted maximum likelihood (REML) with treatment, pooled country, visit, and treatment-by -visit interaction as fixed effects, baseline as covariate, and participant as a random effect. (NCT02152371)
Timeframe: Baseline, 28 Weeks
| Intervention | percentage of change (Least Squares Mean) |
|---|---|
| Dulaglutide + Insulin Glargine | -1.44 |
| Placebo + Insulin Glargine | -0.67 |
The number of cases of acute pancreatitis confirmed by adjudication. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. (NCT02152371)
Timeframe: Baseline through 28 Weeks
| Intervention | participants (Number) |
|---|---|
| Dulaglutide + Insulin Glargine | 0 |
| Placebo + Insulin Glargine | 0 |
Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 12 and 28. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. (NCT02152371)
Timeframe: Baseline, Week 12 and Week 28
| Intervention | participants (Number) |
|---|---|
| Dulaglutide + Insulin Glargine | 0 |
| Placebo + Insulin Glargine | 2 |
Cardiovascular (CV) adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the sponsor. Deaths occurring during the study treatment period and nonfatal CV AEs were to be adjudicated. Nonfatal CV events that were to be adjudicated were myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (CVA/stroke), and transient ischemic attack (TIA). (NCT02152371)
Timeframe: Baseline through 28 Weeks
| Intervention | participants (Number) |
|---|---|
| Dulaglutide + Insulin Glargine | 3 |
| Placebo + Insulin Glargine | 1 |
(NCT02152371)
Timeframe: Baseline through 28 Weeks
| Intervention | participants (Number) |
|---|---|
| Dulaglutide + Insulin Glargine | 1 |
| Placebo + Insulin Glargine | 0 |
(NCT02152371)
Timeframe: 28 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Dulaglutide + Insulin Glargine | 52.7 |
| Placebo + Insulin Glargine | 20.0 |
Percentage of participants who achieved a target HbA1c target of <7%, without weight gain and without documented symptomatic hypoglycemia at 28 weeks were analyzed using regression model, controlling for treatment, pre-treatment, baseline HbA1c and country. (NCT02152371)
Timeframe: 28 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Dulaglutide + Insulin Glargine | 40.7 |
| Placebo + Insulin Glargine | 16.7 |
Percentage of participants achieving target HbA1c of <7.0% at 28 weeks without documented symptomatic hypoglycemia are presented. Documented symptomatic hypoglycemia is defined as any time a participant experienced symptoms and or signs associated with hypoglycemia and had a plasma glucose of <=70 mg/dL. (NCT02152371)
Timeframe: 28 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Dulaglutide + Insulin Glargine | 52.0 |
| Placebo + Insulin Glargine | 28.0 |
(NCT02152371)
Timeframe: Baseline through 28 Weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Dulaglutide + Insulin Glargine | 0 |
| Placebo + Insulin Glargine | 0 |
The rate of total hypoglycemic events any type per 30 days is presented. The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days. (NCT02152371)
Timeframe: Baseline through 28 Weeks
| Intervention | rate of hypoglycemic events per 30 days (Mean) |
|---|---|
| Dulaglutide + Insulin Glargine | 0.63 |
| Placebo + Insulin Glargine | 0.70 |
The LS means of the 7-point SMPG change from baseline to primary endpoint at week 28 was measured using a MMRM analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline SMPG as covariate. (NCT02152371)
Timeframe: Baseline, 28 Weeks
| Intervention | mg/dL (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Pre-Morning Meal (n=133,129) | Morning Meal 2-Hour Postprandial (n=123,119) | Pre-Midday Meal (n=133,127) | Midday Meal 2-Hour Post Prandial (n=123,117) | Pre-Evening Meal (n=133,129) | Evening Meal 2-Hour Postprandial (n=126,122) | 3:00 AM (Morning) (n=124,117) | |
| Dulaglutide + Insulin Glargine | -44.03 | -64.16 | -40.89 | -51.13 | -43.68 | -48.63 | -39.77 |
| Placebo + Insulin Glargine | -35.97 | -46.97 | -25.34 | -32.98 | -28.71 | -27.35 | -20.30 |
Percentage of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country. (NCT02152371)
Timeframe: 28 Weeks
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HbA1c <= 6.5 | HbA1c < 7.0 | |
| Dulaglutide + Insulin Glargine | 50.7 | 69.3 |
| Placebo + Insulin Glargine | 16.7 | 35.3 |
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The percentage of participants with self-reported hypoglycemic events is presented. (NCT02152371)
Timeframe: Baseline through 28 Weeks
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Symptomatic | Asymptomatic | Severe | Nocturnal | Probable Symptomatic | |
| Dulaglutide + Insulin Glargine | 35.3 | 42.7 | 0.7 | 28.0 | 2.7 |
| Placebo + Insulin Glargine | 30.0 | 39.3 | 0.0 | 28.7 | 2.0 |
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24
| Intervention | MG/DL PPG (Mean) |
|---|---|
| Arm 1: Saxagliptin+Metformin XR+Placebo | -35.6 |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | -70.4 |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | -79.6 |
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24
| Intervention | Body weight Kg (Mean) |
|---|---|
| Arm 1: Saxagliptin+Metformin XR+Placebo | 0.00 |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | -2.39 |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | -2.05 |
Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24
| Intervention | mg/dL (Mean) |
|---|---|
| Arm 1: Saxagliptin+Metformin XR+Placebo | -14.0 |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | -31.7 |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | -37.8 |
HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24
| Intervention | % HbA1c (Mean) |
|---|---|
| Arm 1: Saxagliptin+Metformin XR+Placebo | -0.88 |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | -1.20 |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | -1.47 |
Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT01606007)
Timeframe: At Week 24
| Intervention | % of Participants (Number) |
|---|---|
| Arm 1: Saxagliptin+Metformin XR+Placebo | 18.3 |
| Arm 2: Dapagliflozin+Metformin XR+Placebo | 22.2 |
| Arm 3: Saxagliptin+Dapagliflozin+Metformin XR | 41.4 |
Lipid levels such as cholesterol will be examined by standard blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | mg/dL (Mean) |
|---|---|
| Placebo | -0.8 |
| Leu Met Sil 0.5mg | -20.5 |
| Leu Met Sil 1.0mg | -5.9 |
Lipid levels such as HDL will be examined by standard blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | mg/dL (Mean) |
|---|---|
| Placebo | -1.0 |
| Leu Met Sil 0.5mg | -13.3 |
| Leu Met Sil 1.0mg | 1.2 |
CRP levels will be examined by standard blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | mg/L (Geometric Mean) |
|---|---|
| Placebo | 1.02 |
| Leu Met Sil 0.5mg | 1.27 |
| Leu Met Sil 1.0mg | 1.08 |
Change in Circulating Cytokeratin 18 Fragments (M30) from Baseline to Week 16 will be examined through standard blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | U/L (Mean) |
|---|---|
| Placebo | 70.685 |
| Leu Met Sil 0.5mg | 55.386 |
| Leu Met Sil 1.0mg | 37.847 |
Fasting glucose will be examined through standard fasting blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | mg/dL (Mean) |
|---|---|
| Placebo | 0.8 |
| Leu Met Sil 0.5mg | -2.7 |
| Leu Met Sil 1.0mg | -6.3 |
HbA1c will be examined through standard blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | percentage (Mean) |
|---|---|
| Placebo | 0.07 |
| Leu Met Sil 0.5mg | -0.15 |
| Leu Met Sil 1.0mg | -0.11 |
To evaluate the change in hepatic fat content assessed by proton-density-fat-fraction (PDFF) employing magnetic resonance imaging (MRI). (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | percentage (Mean) |
|---|---|
| Placebo | -10.046 |
| Leu Met Sil 0.5mg | 3.083 |
| Leu Met Sil 1.0mg | -4.013 |
Insulin levels will be examined through standard blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | μIU/mL (Mean) |
|---|---|
| Placebo | -8.30 |
| Leu Met Sil 0.5mg | -6.60 |
| Leu Met Sil 1.0mg | -5.30 |
HOMA-IR levels will be examined by standard blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | mU/L (Geometric Mean) |
|---|---|
| Placebo | 0.89 |
| Leu Met Sil 0.5mg | 0.80 |
| Leu Met Sil 1.0mg | 0.85 |
Lipid levels such as LDL will be examined by standard blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | mg/dL (Mean) |
|---|---|
| Placebo | -1.0 |
| Leu Met Sil 0.5mg | -13.3 |
| Leu Met Sil 1.0mg | 1.2 |
Serum AlanineAminotransferase (ALT) will be examined through standard blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | U/L (Mean) |
|---|---|
| Placebo | -4.1 |
| Leu Met Sil 0.5mg | 1.8 |
| Leu Met Sil 1.0mg | -2.7 |
Lipid levels such as triglycerides will be examined by standard blood chemistry (NCT02546609)
Timeframe: Baseline, Day 112
| Intervention | mg/dL (Geometric Mean) |
|---|---|
| Placebo | 1.0 |
| Leu Met Sil 0.5mg | 0.8 |
| Leu Met Sil 1.0mg | 0.9 |
First phase response from the hyperglycemic clamp (NCT01779362)
Timeframe: 3-months after a medication washout
| Intervention | nmol/L (Geometric Mean) |
|---|---|
| Metformin Alone | 1.68 |
| Glargine Followed by Metformin | 1.68 |
| Placebo | 1.68 |
| Liraglutide + Metformin | 1.68 |
Clamp measure of insulin sensitivity (NCT01779362)
Timeframe: 3-months after a medication washout
| Intervention | x 10-5 mmol/kg/min per pmol/L (Geometric Mean) |
|---|---|
| Metformin Alone | 3.53 |
| Glargine Followed by Metformin | 3.38 |
| Placebo | 3.63 |
| Liraglutide + Metformin | 3.49 |
Participants had 12-months of active therapy. Secondary results at the end of active intervention. (NCT01779362)
Timeframe: Secondary analysis was on all participants with a Month 12 visit.
| Intervention | nmol/L (Geometric Mean) | ||
|---|---|---|---|
| ACRPg | Steady State C-peptide | ACRPmax | |
| Glargine Followed by Metformin | 1.88 | 11.6 | 14.1 |
| Liraglutide + Metformin | 2.68 | 21.2 | 10.1 |
| Metformin Alone | 1.93 | 11.7 | 13.4 |
| Placebo | 1.69 | 10.8 | 13.6 |
Clamp measures of ß-cell response, co-primary outcomes (NCT01779362)
Timeframe: 3-months after medication washout (Month 15)
| Intervention | nmol/L (Geometric Mean) | |
|---|---|---|
| Steady State C-peptide | ACPRmax | |
| Glargine Followed by Metformin | 3.58 | 4.32 |
| Liraglutide + Metformin | 3.73 | 4.58 |
| Metformin Alone | 3.65 | 4.61 |
| Placebo | 3.60 | 4.45 |
"Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications" (NCT00909480)
Timeframe: Weeks 0-26
| Intervention | Subjects (Number) |
|---|---|
| IDet | 12 |
| IGlar | 24 |
(NCT00909480)
Timeframe: Week 0, Week 26
| Intervention | kg (Mean) |
|---|---|
| IDet | -0.49 |
| IGlar | 1 |
(NCT00909480)
Timeframe: Week 0, Week 26
| Intervention | percentage point change (Mean) |
|---|---|
| IDet | -0.48 |
| IGlar | -0.74 |
(NCT00909480)
Timeframe: Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| IDet | 6.22 |
| IGlar | 6.09 |
Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am. (NCT00909480)
Timeframe: Week 26
| Intervention | mmol/L (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Before breakfast (N=200, N=197) | 2 hours after breakfast (N=192, N=188) | Before Lunch (N=193, N=189) | 2 hours After Lunch (N=194, N=186) | Before Dinner (N=194, N=186) | 2 hours after dinner (N=192, N=190) | Bedtime (N=190, N=183) | At 3AM (N=193, N=186) | Before Breakfast Next Day (N=197, N=195) | |
| IDet | 5.8 | 9.1 | 7.2 | 9.7 | 8.2 | 10.3 | 9.5 | 6.6 | 5.7 |
| IGlar | 5.9 | 8.7 | 6.6 | 8.8 | 7.5 | 9.8 | 9 | 6.3 | 5.6 |
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | ||
|---|---|---|---|
| Major | Minor | Symptoms only | |
| IDet | 0 | 75 | 128 |
| IGlar | 2 | 118 | 222 |
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | ||
|---|---|---|---|
| Major | Minor | Symptoms only | |
| IDet | 0 | 39 | 76 |
| IGlar | 0 | 30 | 61 |
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | ||
|---|---|---|---|
| Major | Minor | Symptoms only | |
| IDet | 0 | 5 | 6 |
| IGlar | 0 | 8 | 16 |
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00909480)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| All Events | Major | Minor | Symptoms only | |
| IDet | 329 | 0 | 119 | 210 |
| IGlar | 457 | 2 | 156 | 299 |
The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less (NCT00909480)
Timeframe: Week 26
| Intervention | percentage (%) of subjects (Number) | |||
|---|---|---|---|---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All | |
| IDet | 22 | 13 | 5 | 11 |
| IGlar | 30 | 13 | 17 | 21 |
The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7% (NCT00909480)
Timeframe: Week 26
| Intervention | percentage of subjects (Number) | |||
|---|---|---|---|---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All | |
| IDet | 55 | 40 | 31 | 38 |
| IGlar | 70 | 40 | 47 | 53 |
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. (NCT00909480)
Timeframe: Week 26
| Intervention | percentage (%) of subjects (Number) | |||
|---|---|---|---|---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All | |
| IDet | 22 | 7 | 3 | 9 |
| IGlar | 21 | 13 | 13 | 15 |
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. (NCT00909480)
Timeframe: Week 26
| Intervention | percentage (%) of subjects (Number) | |||
|---|---|---|---|---|
| Metformin monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | All | |
| IDet | 48 | 33 | 25 | 32 |
| IGlar | 52 | 33 | 33 | 38 |
The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time. (NCT00909480)
Timeframe: Week 26
| Intervention | mmol/L (Median) | |||
|---|---|---|---|---|
| Metformin Monotherapy | Metformin+TZD | Metformin+2nd OAD other than TZD | Overall | |
| IDet | 0.48 | 0.72 | 0.6 | 0.57 |
| IGlar | 0.67 | 0.84 | 0.71 | 0.71 |
Baseline was defined as value obtained on Day 1 (first day of treatment). Adiponectin was measured in milligrams/liter (mg/L) and values obtained through a central laboratory; normal range was 1.20 to 20.00 mg/L. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | mg/L (Mean) |
|---|---|
| Glucophage XR in Normal Weight Participants | 1.742 |
| Glucophage XR in Overweight Participants | 1.102 |
| Glucophage XR in Obese Participants | 0.050 |
Baseline was defined as value obtained on Day 1 (first day of treatment). C-Reactive Protein (CRP) was measured in milligrams/liter (mg/L) and values were obtained through a central laboratory; normal was less than 5.0 mg/L. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | mg/L (Mean) |
|---|---|
| Glucophage XR in Normal Weight Participants | -0.589 |
| Glucophage XR in Overweight Participants | 3.144 |
| Glucophage XR in Obese Participants | 1.633 |
Baseline was defined as value obtained on Day 1 (first day of treatment). High-density lipoprotein cholesterol (HDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | mmol/L (Mean) |
|---|---|
| Glucophage XR in Normal Weight Participants | 0.056 |
| Glucophage XR in Overweight Participants | 0.024 |
| Glucophage XR in Obese Participants | 0.032 |
Baseline was defined as values obtained on Day 1. Low-density lipoprotein cholesterol (LDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | mmol/L (Mean) |
|---|---|
| Glucophage XR in Normal Weight Participants | -0.306 |
| Glucophage XR in Overweight Participants | -0.143 |
| Glucophage XR in Obese Participants | -0.181 |
For fasting total cholesterol (TC), baseline is defined as Day 1 (first day of treatment). Total cholesterol was measured in millimoles per liter (mmol/L) and obtained through local laboratories. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | mmol/L (Mean) |
|---|---|
| Glucophage XR in Normal Weight Participants | -0.388 |
| Glucophage XR in Overweight Participants | -0.048 |
| Glucophage XR in Obese Participants | -0.144 |
Baseline was defined as value obtained on Day 1 (first day of treatment). Triglycerides (TG) were measured in millimoles per liter (mmol/L)and values obtained through local laboratories. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | mmol/L (Mean) |
|---|---|
| Glucophage XR in Normal Weight Participants | -0.172 |
| Glucophage XR in Overweight Participants | 0.262 |
| Glucophage XR in Obese Participants | -0.041 |
Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | percentage of hemoglobin (Mean) |
|---|---|
| Glucophage XR in Normal Weight Participants | -1.95 |
| Glucophage XR in Overweight Participants | -1.79 |
| Glucophage XR in Obese Participants | -1.68 |
Baseline was defined as value obtained on Day 1 (first day of treatment). PAI-1 (activity) was measured in units/milliliter (U/mL)and values obtained through a central laboratory; normal was less than 25.00 U/mL. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | U/mL (Mean) |
|---|---|
| Glucophage XR in Normal Weight Participants | 0.465 |
| Glucophage XR in Overweight Participants | 1.177 |
| Glucophage XR in Obese Participants | -1.792 |
Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | mmol/L (Mean) |
|---|---|
| Glucophage XR in Normal Weight Participants | -1.979 |
| Glucophage XR in Overweight Participants | -2.171 |
| Glucophage XR in Obese Participants | -2.141 |
Baseline was defined as ECG obtained at the screening visit. ECG was 12-lead. Heart rate (HR) was measured in beats per minute (beats/min). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | beats/min (Mean) |
|---|---|
| Glucophage XR in Normal Weight Participants | 0.4 |
| Glucophage XR in Overweight Participants | 1.2 |
| Glucophage XR in Obese Participants | 1.1 |
Baseline was defined as ECG obtained at the screening visit. A judgment of clinical significance was at the discretion of the investigator. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | participants (Number) |
|---|---|
| Glucophage XR in Normal Weight Participants | 0 |
| Glucophage XR in Overweight Participants | 1 |
| Glucophage XR in Obese Participants | 3 |
Hematology profile = hematocrit, hemoglobin, red blood cell count (RBC), white blood cell count(WBC), lymphocytes, monocytes, basophils, eosinophils, neutrophils, platelet count. Baseline: value obtained at screening or last value obtained before treatment. LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; RBC (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX
Timeframe: Baseline to Week 16
| Intervention | participants (Number) |
|---|---|
| Glucophage XR in Normal Weight Participants | 0 |
| Glucophage XR in Overweight Participants | 0 |
| Glucophage XR in Obese Participants | 0 |
Urinalysis included pH and specific gravity. Baseline defined as values obtained at screening visit. Clinically significant: outside the reference range (low/high)and judged to be significant by the investigator: Specific gravity 1.003 - 1.035; ph 5 - 8. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | participants (Number) |
|---|---|
| Glucophage XR in Normal Weight Participants | 0 |
| Glucophage XR in Overweight Participants | 0 |
| Glucophage XR in Obese Participants | 0 |
Baseline was defined as the value obtained at screening or value obtained on Day 1 before treatment. Diastolic and systolic blood pressure was measured in millimeters of mercury (mm Hg). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | mm Hg (Mean) | |
|---|---|---|
| Week 16 change in diastolic blood pressure | Week 16 change in systolic blood pressure | |
| Glucophage XR in Normal Weight Participants | -2.2 | -4.6 |
| Glucophage XR in Obese Participants | -1.4 | -1.7 |
| Glucophage XR in Overweight Participants | -4.1 | -5.5 |
Baseline defined as value obtained either in screening visit or last value obtained before glucophage XR treatment given on Day 1. Serum chemistries evaluating kidney or liver function: blood urea nitrogen(BUN), serum creatinine (SCr), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin (BR), uric acid (UA). Abnormal increase in kidney and liver function tests defined as 1.25 - less than, equal to (<=)2.6 times (x) upper limit of normal (ULN)in ALT, AST, total BR, UA; abnormal increase defined as 1.25 to <= 5.1 x ULN in BUN. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR. (NCT00778622)
Timeframe: Baseline to Week 16
| Intervention | participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number with Week 16 ALT 1.25 to <= 2.6xULN | Number with Week 16 ALT > 2.6 x ULN | Number with Week 16 AST 1.25 to <= 2.6xULN | Number with Week 16 AST > 2.6 x ULN | Number with Week 16 Total BR 1.25 to <=2.6xULN | Number with Week 16 Total BR > 2.6 x ULN | Number with Week 16 BUN1.25 to <=5.1xULN | Number with Week 16 BUN > 5.1 x ULN | Number with Week 16 UA 1.25 to <=2.6xULN | Number with Week 16 UA > 2.6 x ULN | Number with Week 16 SCr 1.25 to <=2.6xULN | Number with Week 16 SCr > 1.25 x ULN | |
| Glucophage XR in Normal Weight Participants | 2 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
| Glucophage XR in Obese Participants | 9 | 0 | 4 | 0 | 1 | 0 | 0 | 0 | 7 | 0 | 0 | 0 |
| Glucophage XR in Overweight Participants | 11 | 0 | 5 | 0 | 2 | 0 | 1 | 0 | 5 | 0 | 0 | 0 |
Day 1 was first day of treatment. Lactic acidosis defined as elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and increased lactate/pyruvate ratio. Hypoglycemia (low levels of blood glucose) was reported as an adverse event. Safety population included participants who had enrolled in the study and took at least 1 dose of glucophage extended release (glucophage XR). If a subject experienced more than one adverse event, the subject was counted once at the highest severity. (NCT00778622)
Timeframe: Day 1 to Week 16
| Intervention | participants (Number) | |
|---|---|---|
| Lactic Acidosis | Hypoglycemia | |
| Glucophage XR in Normal Weight Participants | 0 | 1 |
| Glucophage XR in Obese Participants | 0 | 0 |
| Glucophage XR in Overweight Participants | 0 | 0 |
To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | kg (Least Squares Mean) |
|---|---|
| Placebo | 0.02 |
| Dapagliflozin 2.5mg | -0.98 |
| Dapagliflozin 5mg | -0.98 |
| Dapagliflozin 10mg | -1.67 |
To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | IU/day (Least Squares Mean) |
|---|---|
| Placebo | 5.08 |
| Dapagliflozin 2.5mg | -1.80 |
| Dapagliflozin 5mg | -0.61 |
| Dapagliflozin 10mg | -1.16 |
To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 3.3 |
| Dapagliflozin 2.5mg | -12.5 |
| Dapagliflozin 5mg | -18.8 |
| Dapagliflozin 10mg | -21.7 |
To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | -0.30 |
| Dapagliflozin 2.5mg | -0.75 |
| Dapagliflozin 5mg | -0.82 |
| Dapagliflozin 10mg | -0.90 |
To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment. (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | Percentage of participants (Least Squares Mean) |
|---|---|
| Placebo | 11.0 |
| Dapagliflozin 2.5mg | 18.1 |
| Dapagliflozin 5mg | 16.8 |
| Dapagliflozin 10mg | 19.7 |
Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets (NCT00673231)
Timeframe: Baseline to Week 24
| Intervention | Participants (Number) |
|---|---|
| Placebo | 54 |
| Dapagliflozin 2.5mg | 22 |
| Dapagliflozin 5mg | 24 |
| Dapagliflozin 10mg | 19 |
To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment. (NCT00660907)
Timeframe: Baseline to Week 52
| Intervention | kg (Least Squares Mean) |
|---|---|
| Dapagliflozin Plus Metformin | -3.22 |
| Glipizide Plus Metformin | 1.44 |
To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone. (NCT00660907)
Timeframe: Baseline to Week 52
| Intervention | percent (Least Squares Mean) |
|---|---|
| Dapagliflozin Plus Metformin | -0.52 |
| Glipizide Plus Metformin | -0.52 |
To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value. (NCT00660907)
Timeframe: Baseline to Week 52
| Intervention | Percentage of participants (Least Squares Mean) |
|---|---|
| Dapagliflozin Plus Metformin | 3.5 |
| Glipizide Plus Metformin | 40.8 |
To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value. (NCT00660907)
Timeframe: Baseline to Week 52
| Intervention | Percentage of participants (Least Squares Mean) |
|---|---|
| Dapagliflozin Plus Metformin | 33.3 |
| Glipizide Plus Metformin | 2.5 |
Estimated glomerular filtration rate (eGFR) will be calculated from serum creatinine measurements at baseline and after 3, 6, 9 and 12 months. Change from baseline at 12 months is reported. (NCT02903511)
Timeframe: 12 months
| Intervention | mL/min/1.73 m^2 (Mean) |
|---|---|
| Metformin | -0.41 |
| Placebo | -3.35 |
Total kidney volume will be measured by MRI (magnetic resonance imaging) at baseline and at 12 months. Percentage change from baseline in height-adjusted total kidney volume is reported. (NCT02903511)
Timeframe: 12 months
| Intervention | percent change (Mean) |
|---|---|
| Metformin | 3.45 |
| Placebo | 3.15 |
Serious adverse events occurring from the time of signing informed consent until the end of the study will be monitored in both treatment arms (NCT02903511)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Metformin | 2 |
| Placebo | 0 |
Percentage of participants who at the end of 12 months are still prescribed the full randomized dose of metformin or placebo, and the percentage of participants who are prescribed at least 50% of the randomized dose (NCT02903511)
Timeframe: 12 months
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Full Dose | 50% Dose | |
| Metformin | 50 | 82 |
| Placebo | 100 | 100 |
Mean change in HbA1c through Week 12 (NCT00943917)
Timeframe: Day 0 to Week 12
| Intervention | percent change (Mean) |
|---|---|
| ITCA 650 20 mcg/Day - STAGE I | -.93 |
| ITCA 650 40 mcg/Day - STAGE I | -0.96 |
| Exenatide Injection - STAGE I | -0.75 |
Mean change in HbA1c through Week 24 (NCT00943917)
Timeframe: Day 0 to Week 24
| Intervention | percent change (Mean) |
|---|---|
| ITCA 650 20/20 | -0.89 |
| ITCA 650 20/60 | -1.26 |
| ITCA 650 40/40 | -0.70 |
| ITCA 650 40/80 | -1.36 |
| Ex Inj/ITCA 650 40 | -1.01 |
| Ex Inj/ITCA 650 60 | -1.51 |
Mean change in HbA1c through Week 48 (NCT00943917)
Timeframe: Day 0 to Week 48
| Intervention | percent change (Mean) |
|---|---|
| ITCA 650 20/20 | -1.13 |
| ITCA 650 20/60 | -1.25 |
| ITCA 650 40/40 | -0.48 |
| ITCA 650 40/80 | -1.40 |
| Ex Inj/ITCA 650 40 | -1.16 |
| Ex Inj/ITCA 650 60 | -1.84 |
Mean change in HbA1c over first 12 weeks (Stage I) (NCT00943917)
Timeframe: Day 0 and Week 12
| Intervention | percent change (Mean) |
|---|---|
| ITCA 650 20 mcg/Day - STAGE I | -0.96 |
| ITCA 650 40 mcg/Day - STAGE I | -1.04 |
| Exenatide Injection - STAGE I | -0.82 |
Mean change in HbA1c through Week 24 (NCT00943917)
Timeframe: Day 0 to Week 24
| Intervention | percent change (Mean) |
|---|---|
| ITCA 650 20/20 | -.89 |
| ITCA 650 20/60 | -1.26 |
| ITCA 650 40/40 | -0.67 |
| ITCA 650 40/80 | -1.36 |
| Ex Inj/ITCA 650 40 | -1.01 |
| Ex Inj/ITCA 650 60 | -1.51 |
Mean change in HbA1c through Week 48 (NCT00943917)
Timeframe: Day 0 to Week 48
| Intervention | percent change (Mean) |
|---|---|
| ITCA 650 20/20 | -1.00 |
| ITCA 650 20/60 | -1.23 |
| ITCA 650 40/40 | -0.69 |
| ITCA 650 40/80 | -1.37 |
| Ex Inj/ITCA 650 40 | -1.45 |
| Ex Inj/ITCA 650 60 | -1.88 |
Primary outcome for years 2002-2008 defined according to American Diabetes Association criteria (fasting plasma glucose level >= 126 mg/dL [7.0 mmol/L] or 2-hour plasma glucose >= 200 mg/dL [11.1 mmol/L], after a 75 gram oral glucose tolerance test (OGTT), and confirmed with a repeat test). (NCT00038727)
Timeframe: Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).
| Intervention | diabetes incidence (cases per 100 person (Number) |
|---|---|
| 1 Original Lifestyle | 5.3 |
| 2 Original Metformin | 6.4 |
| 3 Original Placebo | 7.8 |
All cause-mortality through clinic reports and National Death Index search (NCT00038727)
Timeframe: Outcomes were assessed throughout follow-up from 1996 to 2022. National Death Index search conducted in 2019 using early release data as of Dec 2018.
| Intervention | Participants (Count of Participants) |
|---|---|
| 1 Original Lifestyle | 158 |
| 2 Original Metformin | 152 |
| 3 Original Placebo | 143 |
Aggregate microvascular disease is defined as the average prevalence of 3 components: (1) retinopathy measured by photography (ETDRS of 20 or greater); (2) neuropathy detected by Semmes Weinstein 10 gram monofilament, and (3) nephropathy based on estimated glomerular filtration rate (eGFR by chronic kidney disease (CKD-Epi) equation ) (<45 ml/min, confirmed) and albumin-to-creatinine ratio in spot urine (> 30mg/gm, confirmed). (NCT00038727)
Timeframe: Outcomes were assessed from 2012-2013 (approximately 2 years).
| Intervention | average percentage of participants (Number) |
|---|---|
| 1 Original Lifestyle | 11.3 |
| 2 Original Metformin | 13 |
| 3 Original Placebo | 12.4 |
Measured using coronary artery calcification (CAC). (NCT00038727)
Timeframe: Outcomes were assessed from 2012-2013 (approximately 2 years).
| Intervention | CAC geometric mean in AU (Geometric Mean) | |
|---|---|---|
| Men | Women | |
| 1 Original Lifestyle | 70.1 | 6.0 |
| 2 Original Metformin | 40.2 | 6.1 |
| 3 Original Placebo | 63.7 | 5.3 |
The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo/Sitagliptin | -9.79 |
| Canagliflozin 100 mg | -47.9 |
| Canagliflozin 300 mg | -57.1 |
| Sitagliptin 100 mg | -49.3 |
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo/Sitagliptin | 2.47 |
| Canagliflozin 100 mg | -27.3 |
| Canagliflozin 300 mg | -37.8 |
| Sitagliptin 100 mg | -20.2 |
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -26.2 |
| Canagliflozin 300 mg | -35.2 |
| Sitagliptin 100 mg | -17.7 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo/Sitagliptin | -0.17 |
| Canagliflozin 100 mg | -0.79 |
| Canagliflozin 300 mg | -0.94 |
| Sitagliptin 100 mg | -0.82 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -0.73 |
| Canagliflozin 300 mg | -0.88 |
| Sitagliptin 100 mg | -0.73 |
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo/Sitagliptin | 1.52 |
| Canagliflozin 100 mg | -3.84 |
| Canagliflozin 300 mg | -5.06 |
| Sitagliptin 100 mg | -1.83 |
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -3.53 |
| Canagliflozin 300 mg | -4.65 |
| Sitagliptin 100 mg | -0.66 |
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Sitagliptin | -1.2 |
| Canagliflozin 100 mg | -3.7 |
| Canagliflozin 300 mg | -4.2 |
| Sitagliptin 100 mg | -1.2 |
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -3.8 |
| Canagliflozin 300 mg | -4.2 |
| Sitagliptin 100 mg | -1.3 |
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Sitagliptin | 3.7 |
| Canagliflozin 100 mg | 10.4 |
| Canagliflozin 300 mg | 12.1 |
| Sitagliptin 100 mg | 5.0 |
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | 11.2 |
| Canagliflozin 300 mg | 13.3 |
| Sitagliptin 100 mg | 6.0 |
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo/Sitagliptin | 3.2 |
| Canagliflozin 100 mg | 1.6 |
| Canagliflozin 300 mg | -1.4 |
| Sitagliptin 100 mg | 1.0 |
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | 1.9 |
| Canagliflozin 300 mg | 2.7 |
| Sitagliptin 100 mg | -0.4 |
The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences between each canagliflozin or sitagliptin group and placebo. (NCT01106677)
Timeframe: Week 26
| Intervention | Percentage of patients (Number) |
|---|---|
| Placebo/Sitagliptin | 29.8 |
| Canagliflozin 100 mg | 45.5 |
| Canagliflozin 300 mg | 57.8 |
| Sitagliptin 100 mg | 54.5 |
To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24. (NCT00984867)
Timeframe: Baseline to Week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | -6.84 |
| Dapagliflozin | -21.65 |
To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24. (NCT00984867)
Timeframe: Baseline to Week 24
| Intervention | kg (Least Squares Mean) |
|---|---|
| Placebo | -0.26 |
| Dapagliflozin | -2.14 |
To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24. (NCT00984867)
Timeframe: Baseline to Week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 3.81 |
| Dapagliflozin | -24.11 |
To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24. (NCT00984867)
Timeframe: Baseline to Week 24
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | 0.03 |
| Dapagliflozin | -0.80 |
To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin. (NCT00984867)
Timeframe: Baseline to Week 24
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | 0.04 |
| Dapagliflozin | -0.45 |
To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8. (NCT00984867)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -5.12 |
| Dapagliflozin | -5.98 |
To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value. (NCT00984867)
Timeframe: Baseline to Week 24
| Intervention | Percentage of participants (Least Squares Mean) |
|---|---|
| Placebo | 16.6 |
| Dapagliflozin | 35.3 |
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). (NCT01023581)
Timeframe: Baseline and Week 26.
| Intervention | percentage glycosylated hemoglobin (Least Squares Mean) |
|---|---|
| Placebo | 0.15 |
| Alogliptin 25 QD | -0.52 |
| Alogliptin 12.5 BID | -0.56 |
| Metformin 500 BID | -0.65 |
| Metformin 1000 BID | -1.11 |
| Alogliptin 12.5 BID + Metformin 500 BID | -1.22 |
| Alogliptin 12.5 BID + Metformin 1000 BID | -1.55 |
The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate. (NCT01023581)
Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
| Intervention | mg/dL (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 1 (n=102, 103, 94, 95, 104, 101, 109) | Week 2 (n=105, 112, 105, 102, 108, 106, 111) | Week 4 (n=105, 112, 106, 106, 110, 106, 111) | Week 8 (n=105, 112, 106, 106, 110, 106, 112) | Week 12 (n=105, 112, 106, 106, 110, 106, 112) | Week 16 (n=105, 112, 106, 106, 110, 106, 112) | Week 20 (n=105, 112, 106, 106, 110, 106, 112) | Week 26 (n=105, 112, 106, 106, 110, 106, 112) | |
| Alogliptin 12.5 BID | -11.9 | -11.6 | -16.6 | -12.1 | -14.7 | -14.7 | -12.3 | -9.7 |
| Alogliptin 12.5 BID + Metformin 1000 BID | -36.3 | -43.6 | -44.1 | -43.8 | -44.7 | -47.7 | -44.6 | -45.9 |
| Alogliptin 12.5 BID + Metformin 500 BID | -32.7 | -34.5 | -37.6 | -32.9 | -31.6 | -35.9 | -33.8 | -31.7 |
| Alogliptin 25 QD | -3.9 | -7.4 | -11.5 | -10.9 | -9.7 | -7.1 | -9.2 | -6.1 |
| Metformin 1000 BID | -23.1 | -22.2 | -29.0 | -30.7 | -30.7 | -33.5 | -35.1 | -31.9 |
| Metformin 500 BID | -12.6 | -14.5 | -16.9 | -11.8 | -14.0 | -13.3 | -10.9 | -11.5 |
| Placebo | 5.7 | 4.6 | 7.2 | 7.1 | 11.6 | 10.1 | 8.7 | 12.4 |
"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was assessed at Weeks 4, 8, 12, 16 and 20.~Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate." (NCT01023581)
Timeframe: Baseline and Weeks 4, 8, 12, 16, and 20.
| Intervention | percentage glycosylated hemoglobin (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Week 4 (n=95, 97, 89, 94, 102, 94, 101) | Week 8 (n=102, 104, 104, 103, 108, 102, 111) | Week 12 (n=102, 104, 104, 103, 108, 102, 111) | Week 16 (n=102, 104, 104, 103, 108, 102, 111) | Week 20 (n=102, 104, 104, 103, 108, 102, 111) | |
| Alogliptin 12.5 BID | -0.42 | -0.58 | -0.62 | -0.63 | -0.59 |
| Alogliptin 12.5 BID + Metformin 1000 BID | -0.75 | -1.17 | -1.40 | -1.50 | -1.54 |
| Alogliptin 12.5 BID + Metformin 500 BID | -0.70 | -1.08 | -1.22 | -1.26 | -1.25 |
| Alogliptin 25 QD | -0.34 | -0.51 | -0.53 | -0.58 | -0.57 |
| Metformin 1000 BID | -0.58 | -0.86 | -1.02 | -1.09 | -1.14 |
| Metformin 500 BID | -0.37 | -0.59 | -0.68 | -0.72 | -0.68 |
| Placebo | 0.09 | 0.08 | 0.12 | 0.13 | 0.12 |
The ALT hepatic transaminase levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12.
| Intervention | U/L (Mean) |
|---|---|
| Dapagliflozin | 32.1 |
| Placebo | 38.1 |
The hepatic transaminase AST will be evaluated with standardized methods at week 12 (NCT02113241)
Timeframe: Week 12
| Intervention | U/L (Mean) |
|---|---|
| Dapagliflozin | 31.1 |
| Placebo | 29.5 |
The AUC of glucose will be calculated from the glucose values obtained from the minuted oral glucose tolerance curve at week 12 (NCT02113241)
Timeframe: Week 12
| Intervention | mmol*hr/L (Mean) |
|---|---|
| Dapagliflozin | 1153 |
| Placebo | 1129 |
The AUC will be calculated from the insulin values obtained from the minuted oral glucose tolerance curve at week 12 (NCT02113241)
Timeframe: Week 12
| Intervention | pmol*h/L (Mean) |
|---|---|
| Dapagliflozin | 45016 |
| Placebo | 119704 |
The Body Mass index it's going to be calculated at week 12 with the Quetelet index. (NCT02113241)
Timeframe: Week 12
| Intervention | kg/m^2 (Mean) |
|---|---|
| Dapagliflozin | 32.6 |
| Placebo | 32.1 |
The weight it's going to be measured at week 12 with a bioimpedance balance. (NCT02113241)
Timeframe: Week 12
| Intervention | kilograms (Mean) |
|---|---|
| Dapagliflozin | 81.2 |
| Placebo | 79.6 |
The creatinine levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12.
| Intervention | mmol/L (Mean) |
|---|---|
| Dapagliflozin | 0.07 |
| Placebo | 0.05 |
The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. (NCT02113241)
Timeframe: Week 12
| Intervention | mmHg (Mean) |
|---|---|
| Dapagliflozin | 76 |
| Placebo | 79 |
The fat mass is going to be evaluated at week 12 through bioimpedance. (NCT02113241)
Timeframe: Week 12
| Intervention | kilograms (Mean) |
|---|---|
| Dapagliflozin | 32.7 |
| Placebo | 34.4 |
The glucose at minute 120 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12
| Intervention | mmol/L (Mean) |
|---|---|
| Dapagliflozin | 8.5 |
| Placebo | 8.8 |
The glucose at minute 30 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12
| Intervention | mmol/L (Mean) |
|---|---|
| Dapagliflozin | 10.5 |
| Placebo | 10.0 |
The glucose at minute 60 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12
| Intervention | mmol/L (Mean) |
|---|---|
| Dapagliflozin | 11.1 |
| Placebo | 11.4 |
The glucose at minute 90 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12
| Intervention | mmol/L (Mean) |
|---|---|
| Dapagliflozin | 9.8 |
| Placebo | 9.9 |
The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. (NCT02113241)
Timeframe: Week 12
| Intervention | mmol/L (Mean) |
|---|---|
| Dapagliflozin | 5.7 |
| Placebo | 5.8 |
The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. (NCT02113241)
Timeframe: Week 12
| Intervention | mmol/L (Mean) |
|---|---|
| Dapagliflozin | 1.3 |
| Placebo | 1.3 |
"The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.~Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12." (NCT02113241)
Timeframe: Week 12
| Intervention | index (Mean) |
|---|---|
| Dapagliflozin | 0.35 |
| Placebo | 0.99 |
The c-LDL levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12
| Intervention | mmol/L (Mean) |
|---|---|
| Dapagliflozin | 3.1 |
| Placebo | 2.8 |
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity at week 12. (NCT02113241)
Timeframe: Week 12
| Intervention | index (Mean) |
|---|---|
| Dapagliflozin | 2.7 |
| Placebo | 1.6 |
"Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.~First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12." (NCT02113241)
Timeframe: Week 12
| Intervention | index (Mean) |
|---|---|
| Dapagliflozin | 1463 |
| Placebo | 2198 |
The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. (NCT02113241)
Timeframe: Week 12
| Intervention | mmHg (Mean) |
|---|---|
| Dapagliflozin | 117 |
| Placebo | 121 |
The total cholesterol will be estimated by standardized techniques at week 12. (NCT02113241)
Timeframe: Week 12
| Intervention | mmol/L (Mean) |
|---|---|
| Dapagliflozin | 5.2 |
| Placebo | 4.9 |
The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques. (NCT02113241)
Timeframe: Week 12
| Intervention | mmol/L (Mean) |
|---|---|
| Dapagliflozin | 1.7 |
| Placebo | 1.7 |
The uric acid levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12.
| Intervention | umol/L (Mean) |
|---|---|
| Dapagliflozin | 243.9 |
| Placebo | 339.0 |
The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques. (NCT02113241)
Timeframe: Week 12
| Intervention | centimeters (Mean) |
|---|---|
| Dapagliflozin | 97.6 |
| Placebo | 97.2 |
Change in BMI (body mass index) from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | Kg/m^2 (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -0.8 |
| DAPA (Dapagliflozin Plus Placebo) | -0.66 |
| PCB (Placebo Plus Placebo) | 0.16 |
Change in body weight from baseline to 16 weeks (NCT02613897)
Timeframe: Baseline to 16 weeks
| Intervention | Kg (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -2.28 |
| DAPA (Dapagliflozin Plus Placebo) | -1.76 |
| PCB (Placebo Plus Placebo) | 0.26 |
A measure of the change in fasting plasma glucagon from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | mg/dl (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -28.52 |
| DAPA (Dapagliflozin Plus Placebo) | 26.89 |
| PCB (Placebo Plus Placebo) | 6.88 |
Measure of change in Free Fatty Acids from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | mEq/L (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -0.06 |
| DAPA (Dapagliflozin Plus Placebo) | -0.01 |
| PCB (Placebo Plus Placebo) | 0.00 |
Change in percentage of glucose oxidation from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | percentage of oxidation (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -22.07 |
| DAPA (Dapagliflozin Plus Placebo) | -46.54 |
| PCB (Placebo Plus Placebo) | 4.65 |
Change in lipid oxidation percentage from baseline to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | percentage of oxidation (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -11.87 |
| DAPA (Dapagliflozin Plus Placebo) | 22.02 |
| PCB (Placebo Plus Placebo) | -6.69 |
Change in blood glucose level measured over a 3 month period from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | percentage change in blood glucose level (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -1.67 |
| DAPA (Dapagliflozin Plus Placebo) | -1.46 |
| PCB (Placebo Plus Placebo) | 0.44 |
Measure of change in OGTT from study start to 16 weeks (NCT02613897)
Timeframe: Change from baseline to 16 weeks
| Intervention | mg/dl (Mean) |
|---|---|
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | -49.62 |
| DAPA (Dapagliflozin Plus Placebo) | -44.24 |
| PCB (Placebo Plus Placebo) | 20.26 |
All subjects received a Double-Tracer Oral Glucose Tolerance Test (OGTT) with 75g of glucose containing 14C-glucose together with intravenous primed-continuous infusion of 3(3H)-glucose for 240 minutes, at baseline (prior to) and after 16 weeks of therapy. Blood and urine samples were obtained during the OGTT to determine EGP. (NCT02613897)
Timeframe: Baseline and 16 weeks
| Intervention | mg/kg*min (Mean) | |
|---|---|---|
| Baseline Measurement | 16 weeks | |
| DAPA (Dapagliflozin Plus Placebo) | 2.56 | 2.8 |
| DAPA/SAXA (Dapagliflozin Plus Saxagliptin) | 2.45 | 2.4 |
| PCB (Placebo Plus Placebo) | 1.95 | 2.15 |
Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks
| Intervention | percentage of glycosylated hemoglobin (Least Squares Mean) |
|---|---|
| 1.5 mg LY2189265 | -0.78 |
| 0.75 mg LY2189265 | -0.71 |
| Metformin | -0.56 |
Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate. (NCT01126580)
Timeframe: Baseline, 52 weeks
| Intervention | percentage of glycosylated hemoglobin (Least Squares Mean) |
|---|---|
| 1.5 mg LY2189265 | -0.70 |
| 0.75 mg LY2189265 | -0.55 |
| Metformin | -0.51 |
The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score. (NCT01126580)
Timeframe: 52 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| 1.5 mg LY2189265 | 12.92 |
| 0.75 mg LY2189265 | 12.73 |
| Metformin | 12.58 |
Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. (NCT01126580)
Timeframe: 4 weeks, 13 weeks, 26 weeks, and 52 weeks
| Intervention | nanogram hours per milliliter (ng*hr/mL) (Mean) |
|---|---|
| 1.5 mg LY2189265 | 12036 |
| 0.75 mg LY2189265 | 5919 |
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 52 weeks plus 30-day follow up
| Intervention | participants (Number) |
|---|---|
| 1.5 mg LY2189265 | 0 |
| 0.75 mg LY2189265 | 0 |
| Metformin | 0 |
A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The total number of treatment emergent ADA was not analyzed at 26 weeks. (NCT01126580)
Timeframe: Baseline through 52 weeks
| Intervention | participants (Number) |
|---|---|
| 1.5 mg or 0.75 mg LY2189265 | 10 |
Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | milliliters of mercury (mmHg) (Least Squares Mean) | |||
|---|---|---|---|---|
| SBP, 26 weeks (n=244, 251, 239) | SBP, 52 weeks (n=221, 219, 215) | DBP, 26 weeks (n=244, 251, 239) | DBP, 52 weeks (n=221, 219, 215) | |
| 0.75 mg LY2189265 | -2.61 | -2.74 | -1.02 | -1.37 |
| 1.5 mg LY2189265 | -1.89 | -0.11 | 0.05 | 0.31 |
| Metformin | -0.91 | -0.98 | -0.64 | -0.38 |
Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline BMI as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | kilograms per meter squared (kg/m^2) (Least Squares Mean) | |
|---|---|---|
| 26 weeks | 52 weeks | |
| 0.75 mg LY2189265 | -0.51 | -0.42 |
| 1.5 mg LY2189265 | -0.86 | -0.73 |
| Metformin | -0.82 | -0.83 |
Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline body weight as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | kilograms (kg) (Least Squares Mean) | |
|---|---|---|
| 26 weeks (n=267, 269, 267) | 52 weeks (n=267, 269, 267) | |
| 0.75 mg LY2189265 | -1.36 | -1.09 |
| 1.5 mg LY2189265 | -2.29 | -1.93 |
| Metformin | -2.22 | -2.20 |
The SMBG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (daily mean) were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline daily mean as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | millimoles per liter (mmol/L) (Least Squares Mean) | |
|---|---|---|
| 26 weeks (n=195, 200, 211) | 52 weeks (n=197, 200, 212) | |
| 0.75 mg LY2189265 | -1.75 | -1.71 |
| 1.5 mg LY2189265 | -1.98 | -1.99 |
| Metformin | -1.68 | -1.58 |
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | milliseconds (msec) (Least Squares Mean) | |||
|---|---|---|---|---|
| QTcF interval, 26 weeks (n=230, 237, 221) | QTcF interval, 52 weeks (n=212, 212, 205) | PR interval, 26 weeks (n=226, 235, 218) | PR interval, 52 weeks (n=209, 210, 201) | |
| 0.75 mg LY2189265 | 1.38 | 0.73 | -0.01 | 1.53 |
| 1.5 mg LY2189265 | 2.60 | 3.76 | -0.04 | 1.15 |
| Metformin | -0.91 | -0.53 | -2.04 | -2.88 |
Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects and baseline interval as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | beats per minute (bpm) (Least Squares Mean) | |
|---|---|---|
| 26 weeks (n=230, 237, 221) | 52 weeks (n=212, 212, 205) | |
| 0.75 mg LY2189265 | 2.57 | 2.36 |
| 1.5 mg LY2189265 | 1.60 | 2.02 |
| Metformin | 0.82 | 1.27 |
Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | millimoles per liter (mmol/L) (Least Squares Mean) | |
|---|---|---|
| 26 weeks (n=244, 247, 245) | 52 weeks (n=207, 210, 194) | |
| 0.75 mg LY2189265 | -1.46 | -1.00 |
| 1.5 mg LY2189265 | -1.61 | -1.56 |
| Metformin | -1.34 | -1.15 |
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline HOMA2 as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | percentage of HOMA2 (Least Squares Mean) | |||
|---|---|---|---|---|
| HOMA2-%B, 26 weeks (n=207, 207, 215) | HOMA2-%B, 52 weeks (n=179, 185, 170) | HOMA2-%S, 26 weeks (n=207, 207, 215) | HOMA2-%S, 52 weeks (n=179, 185, 170) | |
| 0.75 mg LY2189265 | 28.96 | 22.5 | 2.71 | 1.84 |
| 1.5 mg LY2189265 | 36.55 | 29.97 | 0.95 | 5.29 |
| Metformin | 14.11 | 9.77 | 9.99 | 10.83 |
Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | units per liter (U/L) (Median) | |||||
|---|---|---|---|---|---|---|
| Amylase (total), 26 weeks | Amylase (total), 52 weeks | Amylase (PD), 26 weeks | Amylase (PD), 52 weeks | Lipase, 26 weeks | Lipase, 52 weeks | |
| 0.75 mg LY2189265 | 6.00 | 5.00 | 4.00 | 3.00 | 5.00 | 5.00 |
| 1.5 mg LY2189265 | 7.00 | 5.50 | 5.00 | 4.00 | 7.00 | 5.00 |
| Metformin | 4.00 | 4.00 | 1.00 | 2.00 | 1.00 | 1.00 |
Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | beats per minute (bpm) (Least Squares Mean) | |
|---|---|---|
| 26 weeks (n=244, 251, 239) | 52 weeks (n=221, 219, 215) | |
| 0.75 mg LY2189265 | 2.14 | 1.63 |
| 1.5 mg LY2189265 | 2.39 | 1.84 |
| Metformin | 1.59 | 1.12 |
(NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | picograms per milliliter (pcg/mL) (Median) | |
|---|---|---|
| 26 weeks | 52 weeks | |
| 0.75 mg LY2189265 | 0.00 | 0.00 |
| 1.5 mg LY2189265 | 0.00 | 0.00 |
| Metformin | 0.00 | 0.00 |
"The Diabetes Symptoms Checklist-revised (DSC-r) was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychology-fatigue, psychology-cognitive, neurology-pain, neurology-sensory, cardiology, ophthalmology, hypoglycemia, and hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score." (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| 26 weeks (n=245, 253, 248) | 52 weeks (n=247, 255, 249) | |
| 0.75 mg LY2189265 | -0.16 | 0.42 |
| 1.5 mg LY2189265 | 0.24 | 0.49 |
| Metformin | 0.41 | 0.59 |
The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| 26 weeks (n=244, 249, 241) | 52 weeks (n=245, 251, 244) | |
| 0.75 mg LY2189265 | 1.81 | 1.29 |
| 1.5 mg LY2189265 | 1.93 | 1.82 |
| Metformin | 2.04 | 1.94 |
"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score." (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| 26 weeks (n=247, 251, 247) | 52 weeks (n=247, 252, 248) | |
| 0.75 mg LY2189265 | 0.19 | -0.05 |
| 1.5 mg LY2189265 | 0.09 | 0.39 |
| Metformin | 0.02 | 0.28 |
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| 26 weeks (n=248, 254, 249) | 52 weeks (n=249, 255, 250) | |
| 0.75 mg LY2189265 | 0.63 | 0.61 |
| 1.5 mg LY2189265 | 0.72 | 0.45 |
| Metformin | 0.79 | 0.75 |
Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 52 weeks plus 30-day follow up
| Intervention | participants (Number) | ||
|---|---|---|---|
| Any CV Event | Any Fatal CV Event | Any Nonfatal CV Event | |
| 0.75 mg LY2189265 | 2 | 0 | 2 |
| 1.5 mg LY2189265 | 1 | 0 | 1 |
| Metformin | 1 | 0 | 1 |
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: 26 weeks and 52 weeks
| Intervention | participants (Number) | |
|---|---|---|
| 26 weeks | 52 weeks | |
| 0.75 mg LY2189265 | 150 | 177 |
| 1.5 mg LY2189265 | 163 | 179 |
| Metformin | 151 | 170 |
Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 26 weeks and 52 weeks
| Intervention | events (Number) | |||||
|---|---|---|---|---|---|---|
| Severe, 26 weeks (n=241, 248, 236) | Severe, 52 weeks (n=214, 217, 199) | Documented Symptomatic, 26 weeks (n=241, 248, 236) | Documented Symptomatic, 52 weeks (n=214, 217, 199) | Asymptomatic, 26 weeks (n=241, 248, 236) | Asymptomatic, 52 weeks (n=214, 217, 199) | |
| 0.75 mg LY2189265 | 0 | 0 | 6 | 8 | 9 | 9 |
| 1.5 mg LY2189265 | 0 | 0 | 2 | 7 | 19 | 5 |
| Metformin | 0 | 0 | 2 | 2 | 13 | 9 |
Percent changes in total cholesterol were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | percentage change in total cholesterol (Median) | |
|---|---|---|
| 26 weeks (n=244, 244, 243) | 52 weeks (n=247, 248, 245) | |
| 0.75 mg LY2189265 | -1.77 | -0.78 |
| 1.5 mg LY2189265 | -3.86 | -1.69 |
| Metformin | -3.51 | -3.88 |
Percentage changes in HDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | percentage change in HDL-C (Median) | |
|---|---|---|
| 26 weeks (n=246, 244, 244) | 52 weeks (n=248, 248, 246) | |
| 0.75 mg LY2189265 | 4.20 | 2.31 |
| 1.5 mg LY2189265 | 2.39 | 4.95 |
| Metformin | 5.78 | 4.32 |
Percentage changes in LDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | percentage change in LDL-C (Median) | |
|---|---|---|
| 26 weeks (n=233, 231, 221) | 52 weeks (n=236, 240, 231) | |
| 0.75 mg LY2189265 | -2.70 | -2.34 |
| 1.5 mg LY2189265 | -6.86 | -2.06 |
| Metformin | -8.97 | -7.23 |
Percentage changes in triglycerides were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks
| Intervention | percentage change in triglycerides (Median) | |
|---|---|---|
| 26 weeks (n=252, 252, 253) | 52 weeks (n=255, 256, 254) | |
| 0.75 mg LY2189265 | -1.96 | -0.86 |
| 1.5 mg LY2189265 | -2.35 | -4.27 |
| Metformin | 2.56 | 1.91 |
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, prior medication group, and treatment as factors included in the model. (NCT01126580)
Timeframe: 26 weeks and 52 weeks
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| HbA1c less than 7%, 26 weeks | HbA1c less than or equal to 6.5%, 26 weeks | HbA1c less than 7%, 52 weeks | HbA1c less than or equal to 6.5%, 52 weeks | |
| 0.75 mg LY2189265 | 62.6 | 40.0 | 53.2 | 34.7 |
| 1.5 mg LY2189265 | 61.5 | 46.0 | 60.0 | 42.3 |
| Metformin | 53.6 | 29.8 | 48.3 | 28.3 |
Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 52 weeks
| Intervention | events per participant per year (Mean) | ||
|---|---|---|---|
| Severe | Documented Symptomatic | Asymptomatic | |
| 0.75 mg LY2189265 | 0.00 | 0.15 | 0.30 |
| 1.5 mg LY2189265 | 0.00 | 0.62 | 0.24 |
| Metformin | 0.00 | 0.09 | 0.18 |
Percent of BG between 70 and 180 mg/dL, as measured using Continuous Glucose Monitor (CGM) (NCT03199638)
Timeframe: baseline vs. at 3 months
| Intervention | Percentage of Blood Glucose (Mean) | |
|---|---|---|
| baseline | at 3 months | |
| an Exercise + Glutamine Group | 57.6 | 69.2 |
| an Exercise Group | 63.7 | 46.4 |
MAGE describes the average amplitude of glycemic variations measured using continuous glucose monitoring (CGM) (NCT03199638)
Timeframe: before vs. at 3 months
| Intervention | mg/dL (Mean) | |
|---|---|---|
| baseline | at 3 months | |
| an Exercise + Glutamine Group | 108 | 123 |
| an Exercise Group | 129 | 139 |
change in glycated hemoglobin (NCT03199638)
Timeframe: baseline vs. at 3 months
| Intervention | percentage of total hemoglobin (Mean) | |
|---|---|---|
| baseline | at 3 months | |
| an Exercise + Glutamine Group | 8.3 | 8.4 |
| an Exercise Group | 7.9 | 8.0 |
Change in insulin dose (Units/kg/day) used at home (NCT03199638)
Timeframe: baseline vs. at 3 months
| Intervention | Units/kg/day (Mean) | |
|---|---|---|
| baseline | at 3 months | |
| an Exercise + Glutamine Group | 0.98 | 1.0 |
| an Exercise Group | 1.0 | 0.8 |
Change in insulin sensitivity score, determined using SEARCH ISS model published equation: logeIS = 4.64725 - 0.02032 × (waist, cm) - 0.09779 × (HbA1c, %) - 0.00235 × (Triglycerides, mg/dL). The range of ISS scores is between 1-15. Higher scores imply a better insulin sensistivity. (NCT03199638)
Timeframe: baseline vs. at 3 months
| Intervention | score on a scale (Mean) | |
|---|---|---|
| baseline | at 3 months | |
| an Exercise + Glutamine Group | 2.10 | 2.16 |
| an Exercise Group | 2.17 | 2.20 |
Change in Percent of BG above 180 mg, as determined using Continuous Glucose Monitor (CGM) (NCT03199638)
Timeframe: baseline vs. at 3 months
| Intervention | Percentage of Blood Glucose (Mean) | |
|---|---|---|
| basline | at 3 months | |
| an Exercise + Glutamine Group | 39.4 | 26.6 |
| an Exercise Group | 29.1 | 46.4 |
Change in Percent of BG below 70 mg/dL, as determined by Continuous Glucose Monitor (CGM) (NCT03199638)
Timeframe: baseline vs. at 3 months
| Intervention | Percentage of Blood Glucose (Mean) | |
|---|---|---|
| baseline | at 3 months | |
| an Exercise + Glutamine Group | 3.1 | 4.4 |
| an Exercise Group | 7.2 | 7.2 |
Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: baseline, week 30
| Intervention | kg (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -2.45 |
| Insulin Lispro (BBT) | 2.11 |
Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: baseline, Week 30
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -0.64 |
| Insulin Lispro (BBT) | -0.14 |
Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: Baseline, Week 30
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -0.46 |
| Insulin Lispro (BBT) | 0.18 |
Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline). (NCT00960661)
Timeframe: Baseline, 30 weeks
| Intervention | percent of hemoglobin (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -1.13 |
| Insulin Lispro (BBT) | -1.10 |
Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. (NCT00960661)
Timeframe: Baseline, week 30
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -0.04 |
| Insulin Lispro (BBT) | 0.03 |
Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. (NCT00960661)
Timeframe: Baseline, Week 30
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -0.12 |
| Insulin Lispro (BBT) | -0.03 |
Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects. (NCT00960661)
Timeframe: Baseline, Week 30
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -4.13 |
| Insulin Lispro (BBT) | 0.37 |
Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate. (NCT00960661)
Timeframe: Baseline, week 30
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide (BET) | -0.14 |
| Insulin Lispro (BBT) | -0.03 |
Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and requiring the assistance of another person because of severe impairment in consciousness or behavior. (NCT00960661)
Timeframe: 30 weeks
| Intervention | rate per year (Mean) |
|---|---|
| Exenatide (BET) | 0.0 |
| Insulin Lispro (BBT) | 0.1 |
Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) (NCT00960661)
Timeframe: 30 weeks
| Intervention | rate per year (Mean) |
|---|---|
| Exenatide (BET) | 2.1 |
| Insulin Lispro (BBT) | 5.0 |
Percent of participants achieving HbA1c ≤ 6.5%. (NCT00960661)
Timeframe: Week 30
| Intervention | percentage of participants (Number) |
|---|---|
| Exenatide (BET) | 26.2 |
| Insulin Lispro (BBT) | 25.5 |
Percentage of participants achieving HbA1C < 7.0% (NCT00960661)
Timeframe: Week 30
| Intervention | Percentage of participants (Number) |
|---|---|
| Exenatide (BET) | 46.7 |
| Insulin Lispro (BBT) | 42.6 |
Daily Insulin Glargine Dose at baseline and at Week 30 (NCT00960661)
Timeframe: Baseline, week 30
| Intervention | IU/day (Mean) | |
|---|---|---|
| Baseline | Week 30 | |
| Exenatide (BET) | 61.5 | 56.9 |
| Insulin Lispro (BBT) | 61.1 | 51.5 |
change in A1c (%) from baseline to end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | % change of A1c (Mean) |
|---|---|
| Treatment Group | -2.38 |
| Control Group | -0.83 |
change (mmHg) of systolic BP from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | mmHg (Mean) |
|---|---|
| Treatment Group | -16 |
| Control Group | 15 |
change (beats/min) from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks
| Intervention | beats per min (Mean) |
|---|---|
| Treatment Group | 4.3 |
| Control Group | 5.13 |
change (mg/dL) from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | mg/dL (Mean) |
|---|---|
| Treatment Group | -15.7 |
| Control Group | 21 |
change (mg/dL) from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | mg/dL (Mean) |
|---|---|
| Treatment Group | 0.04 |
| Control Group | 0.04 |
change (mg/dL) from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | mg/dL (Mean) |
|---|---|
| Treatment Group | -18.5 |
| Control Group | 18.38 |
"Patient satisfaction with treatment in both groups will be measured by the validated the Diabetes Medications Satisfaction Tool (DM-SAT). Response options range from 0=not at all satisfied to 10=extremely satisfied and a total score is calculated ranging from 0 to 100, with higher scores indicating more diabetes medication satisfaction." (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | score on a scale (Mean) |
|---|---|
| Treatment Group | 45.3 |
| Control Group | 4.63 |
change (in pounds) from baseline to the end of study at 16 weeks (NCT02846233)
Timeframe: 16 weeks (from baseline to end of study at 16 weeks)
| Intervention | pounds (Mean) |
|---|---|
| Treatment Group | -16.38 |
| Control Group | -0.1 |
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment. (NCT01217892)
Timeframe: Baseline to Week 1
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Dapagliflozin 2.5mg BID Plus Metformin | -13.7 |
| Dapagliflozin 5mg BID Plus Metformin | -14.7 |
| Dapagliflozin 10mg OD Plus Metformin | -15.5 |
| Placebo Plus Metformin | 2.0 |
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment. (NCT01217892)
Timeframe: Baseline to Week 16
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Dapagliflozin 2.5mg BID Plus Metformin | -20.8 |
| Dapagliflozin 5mg BID Plus Metformin | -25.6 |
| Dapagliflozin 10mg OD Plus Metformin | -20.4 |
| Placebo Plus Metformin | -10.4 |
To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment. (NCT01217892)
Timeframe: Baseline to Week 16
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Dapagliflozin 2.5mg BID Plus Metformin | -0.52 |
| Dapagliflozin 5mg BID Plus Metformin | -0.65 |
| Dapagliflozin 10mg OD Plus Metformin | -0.59 |
| Placebo Plus Metformin | -0.30 |
To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment. (NCT01217892)
Timeframe: Baseline to Week 16
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Dapagliflozin 2.5mg BID Plus Metformin | -2.84 |
| Dapagliflozin 5mg BID Plus Metformin | -3.20 |
| Dapagliflozin 10mg OD Plus Metformin | -2.76 |
| Placebo Plus Metformin | -1.04 |
To compare the adjusted proportions controlling for baseline HbA1c [acc. to Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu] of participants with HbA1c <7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline. (NCT01217892)
Timeframe: Baseline to Week 16
| Intervention | Percentage of participants (Least Squares Mean) |
|---|---|
| Dapagliflozin 2.5mg BID Plus Metformin | 33.6 |
| Dapagliflozin 5mg BID Plus Metformin | 38.2 |
| Dapagliflozin 10mg OD Plus Metformin | 28.1 |
| Placebo Plus Metformin | 21.4 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change. (NCT00968812)
Timeframe: Baseline, Week 104
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -0.65 |
| Canagliflozin 300 mg | -0.74 |
| Glimepiride | -0.55 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -0.82 |
| Canagliflozin 300 mg | -0.93 |
| Glimepiride | -0.81 |
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -4.2 |
| Canagliflozin 300 mg | -4.7 |
| Glimepiride | 1.0 |
The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percentage of patients (Number) |
|---|---|
| Canagliflozin 100 mg | 5.6 |
| Canagliflozin 300 mg | 4.9 |
| Glimepiride | 34.2 |
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528372)
Timeframe: Baseline to Week 1 (end of Short-term Period)
| Intervention | mg/dL (Mean) |
|---|---|
| Group 1: Dapagliflozin Placebo AM & PM | -2.4 |
| Group 1: Dapagliflozin, 2.5 mg AM | -2.9 |
| Group 1: Dapagliflozin, 5 mg AM | -16.4 |
| Group 1: Dapagliflozin, 10 mg AM | -16.1 |
| Group 1: Dapagliflozin, 2.5 mg PM | -14.4 |
| Group 1: Dapagliflozin, 5 mg PM | -18.6 |
| Group 1: Dapagliflozin, 10 mg PM | -20.3 |
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528372)
Timeframe: Baseline to Week 1
| Intervention | mg/dL (Mean) |
|---|---|
| Group 2: Dapagliflozin, 5 mg AM | -54.3 |
| Group 2: Dapagliflozin, 10 mg AM | -74.3 |
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)
| Intervention | Percent (Mean) |
|---|---|
| Group 1: Dapagliflozin Placebo AM & PM | -0.21 |
| Group 1: Dapagliflozin, 2.5 mg AM | -0.58 |
| Group 1: Dapagliflozin, 5 mg AM | -0.73 |
| Group 1: Dapagliflozin, 10 mg AM | -0.88 |
| Group 1: Dapagliflozin, 2.5 mg PM | -0.81 |
| Group 1: Dapagliflozin, 5 mg PM | -0.76 |
| Group 1: Dapagliflozin, 10 mg PM | -0.80 |
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)
| Intervention | mg/dL (Mean) |
|---|---|
| Group 1: Dapagliflozin Placebo AM & PM | -4.1 |
| Group 1: Dapagliflozin, 2.5 mg AM | -15.2 |
| Group 1: Dapagliflozin, 5 mg AM | -24.1 |
| Group 1: Dapagliflozin, 10 mg AM | -28.8 |
| Group 1: Dapagliflozin, 2.5 mg PM | -25.6 |
| Group 1: Dapagliflozin, 5 mg PM | -27.3 |
| Group 1: Dapagliflozin, 10 mg PM | -29.6 |
Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)
| Intervention | mg/dL (Mean) |
|---|---|
| Group 2: Dapagliflozin, 5 mg AM | -77. |
| Group 2: Dapagliflozin, 10 mg AM | -84.3 |
HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)
| Intervention | Percent (Mean) |
|---|---|
| Group 1: Dapagliflozin Placebo AM & PM | -0.23 |
| Group 1: Dapagliflozin, 2.5 mg AM | -0.58 |
| Group 1: Dapagliflozin, 5 mg AM | -0.77 |
| Group 1: Dapagliflozin, 10 mg AM | -0.89 |
| Group 1: Dapagliflozin, 2.5 mg PM | -0.83 |
| Group 1: Dapagliflozin, 5 mg PM | -0.79 |
| Group 1: Dapagliflozin, 10 mg PM | -0.79 |
HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)
| Intervention | Percent (Mean) |
|---|---|
| Group 2: Dapagliflozin, 5 mg AM | -2.88 |
| Group 2: Dapagliflozin, 10 mg AM | -2.66 |
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had baseline HbA1c >9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study drug. In cases where time of the first dose or assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study drug. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)
| Intervention | Percent (Mean) |
|---|---|
| Group 1: Dapagliflozin Placebo AM & PM | 0.19 |
| Group 1: Dapagliflozin, 2.5 mg AM | -1.26 |
| Group 1: Dapaglifozon, 5 mg AM | -2.00 |
| Group 1: Dapagliflozin, 10 mg AM | -2.04 |
| Group 1: Dapagliflozin, 2.5 mg PM | -1.35 |
| Group 1: Dapagliflozin, 5 mg PM | -1.53 |
| Group 1: Dapagliflozin, 10 mg PM | -1.21 |
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available) was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)
| Intervention | Kilograms (Mean) |
|---|---|
| Group 1: Dapagliflozin Placebo AM & PM | -2.43 |
| Group 1: Dapagliflozin, 2.5 mg AM | -3.43 |
| Group 1: Dapagliflozin, 5 mg AM | -2.91 |
| Group 1: Dapagliflozin, 10 mg AM | -3.39 |
| Group 1: Dapagliflozin, 2.5 mg PM | -4.30 |
| Group 1: Dapagliflozin, 5 mg PM | -3.70 |
| Group 1: Dapagliflozin, 10 mg PM | -3.39 |
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528372)
Timeframe: From Baseline to Week 24 (end of Short-term Period)
| Intervention | Kilograms (Mean) |
|---|---|
| Group 1: Dapagliflozin Placebo AM & PM | -2.19 |
| Group 1: Dapagliflozin, 2.5 mg AM | -3.25 |
| Group 1: Dapagliflozin, 5 mg AM | -2.83 |
| Group 1: Dapagliflozin, 10 mg AM | -3.16 |
| Group 1: Dapagliflozin, 2.5 mg PM | -3.82 |
| Group 1: Dapagliflozin, 5 mg PM | -3.55 |
| Group 1: Dapagliflozin, 10 mg PM | -3.05 |
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. (NCT00528372)
Timeframe: From Baseline to Week 24 (end of Short-term Period)
| Intervention | Kilograms (Mean) |
|---|---|
| Group 2: Dapagliflozin, 5 mg AM | -2.06 |
| Group 2: Dapagliflozin, 10 mg AM | -1.90 |
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)
| Intervention | Percentage of participants (Number) |
|---|---|
| Group 1: Dapagliflozin Placebo AM & PM | 31.6 |
| Group 1: Dapagliflozin, 2.5 mg AM | 41.3 |
| Group 1: Dapagliflozin, 5 mg AM | 44.2 |
| Group 1: Dapagliflozin, 10 mg AM | 50.8 |
| Group 1: Dapagliflozin, 2.5 mg PM | 51.4 |
| Group 1: Dapagliflozin, 5 mg PM | 44.0 |
| Group 1: Dapagliflozin, 10 mg PM | 51.6 |
Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)
| Intervention | Percentage of participants (Number) |
|---|---|
| Group 1: Dapagliflozin Placebo AM & PM | 14.5 |
| Group 1: Dapagliflozin, 2.5 mg AM | 27.2 |
| Group 1: Dapagliflozin, 5 mg AM | 26.6 |
| Group 1: Dapagliflozin, 10 mg AM | 23.1 |
| Group 1: Dapagliflozin, 2.5 mg PM | 33.4 |
| Group 1: Dapagliflozin, 5 mg PM | 25.8 |
| Group 1: Dapagliflozin, 10 mg PM | 26.0 |
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days. (NCT00528372)
Timeframe: Day 1 to Week 102 (end of Long-term Period) + 30 days
| Intervention | Participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| >=1 AE | >=1 Hypoglycemia | >=1 Related AEs | Deaths | SAEs | >=1 related SAE | SAEs leading to discontinuation | AE leading to discontinuation | Hypoglycemia leading to discontinuation | |
| Group 1: Dapagliflozin Placebo, AM & PM | 58 | 4 | 15 | 0 | 5 | 0 | 1 | 4 | 0 |
| Group 1: Dapagliflozin, 10 mg AM | 56 | 3 | 17 | 1 | 1 | 0 | 0 | 5 | 0 |
| Group 1: Dapagliflozin, 10 mg PM | 54 | 2 | 21 | 0 | 3 | 0 | 1 | 7 | 0 |
| Group 1: Dapagliflozin, 2.5 mg AM | 48 | 3 | 13 | 0 | 6 | 0 | 0 | 4 | 0 |
| Group 1: Dapagliflozin, 2.5 mg PM | 50 | 2 | 19 | 1 | 7 | 0 | 1 | 2 | 0 |
| Group 1: Dapagliflozin, 5 mg AM | 43 | 0 | 10 | 0 | 4 | 0 | 1 | 4 | 0 |
| Group 1: Dapagliflozin, 5 mg PM | 50 | 0 | 18 | 1 | 5 | 0 | 2 | 6 | 0 |
| Group 2: Dapagliflozin, 10 mg AM | 33 | 1 | 10 | 0 | 0 | 0 | 0 | 1 | 0 |
| Group 2: Dapagliflozin, 5 mg AM | 29 | 1 | 12 | 0 | 1 | 0 | 0 | 0 | 0 |
12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)
| Intervention | Participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline: Normal/Week 24: Normal | Baseline: Normal/Week 24: Abnormal | Baseline: Normal/Week 24: Not reported | Baseline: Abnormal/Week 24: Normal | Baseline: Abnormal/Week 24: Abnormal | Baseline: Abnormal/Week 24: Not reported | Baseline: Not reported/Week 24: Normal | Basline: Not reported/Week 24: Abnormal | Baseline: Not reported/Week 24: Not reported | |
| Group 1: Dapagliflozin Placebo AM & PM | 38 | 6 | 0 | 5 | 18 | 0 | 0 | 0 | 8 |
| Group 1: Dapagliflozin, 10 mg AM | 31 | 1 | 0 | 6 | 17 | 0 | 0 | 0 | 15 |
| Group 1: Dapagliflozin, 10 mg PM | 35 | 10 | 0 | 10 | 11 | 0 | 0 | 0 | 10 |
| Group 1: Dapagliflozin, 2.5 mg AM | 36 | 3 | 0 | 2 | 17 | 0 | 0 | 0 | 7 |
| Group 1: Dapagliflozin, 2.5 mg PM | 33 | 3 | 0 | 4 | 17 | 0 | 0 | 0 | 10 |
| Group 1: Dapagliflozin, 5 mg AM | 32 | 5 | 0 | 3 | 11 | 0 | 0 | 0 | 13 |
| Group 1: Dapagliflozin, 5 mg PM | 33 | 6 | 0 | 4 | 14 | 0 | 0 | 0 | 11 |
Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Day 1 to Week 102 (end of Long-term Period)
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| AST >3*ULN (n=75, 65, 62, 70, 67, 67, 74, 34, 37)) | AST >5*ULN (n=75, 65, 62, 70, 67, 67, 74) | ALT >3*ULN (n=75, 65, 62, 70, 67, 67, 74) | ALT >5*ULN (n=75, 65, 62, 70, 67, 67, 74) | Bilirubin >1.5 ULN (n=75, 65, 62, 70, 67, 67, 74) | Bilirubin >2*ULN (n=75, 65, 62, 70, 67, 67, 74) | ALP >1.5*ULN (n=75, 65, 62, 70, 67, 67, 74) | |
| Group 1: Dapagliflozin Placebo AM & PM | 0 | 0 | 1 | 0 | 2 | 0 | 4 |
| Group 1: Dapagliflozin, 10 mg AM | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Group 1: Dapagliflozin, 10 mg PM | 4 | 0 | 0 | 0 | 0 | 0 | 2 |
| Group 1: Dapagliflozin, 2.5 mg AM | 1 | 0 | 1 | 1 | 0 | 0 | 3 |
| Group 1: Dapagliflozin, 2.5 mg PM | 5 | 2 | 0 | 0 | 2 | 1 | 4 |
| Group 1: Dapagliflozin, 5 mg AM | 1 | 0 | 2 | 0 | 1 | 0 | 1 |
| Group 1: Dapagliflozin, 5 mg PM | 1 | 0 | 0 | 0 | 1 | 0 | 3 |
Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as >=5.6 mg/dL for ages 17-65 years or >=5.1 mg/dL for ages >=66. (NCT00528372)
Timeframe: Baseline to Week 102 (end of Long-term Period)
| Intervention | Participants (Number) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hematocrit (>55%) | Hematocrit (>60%) | Hemoglobin (>18 g/dL) | Glucose ( >350 mg/dL) | Glucose (<54 mg/dL) | Creatine kinase (>5*ULN) | Creatine kinase (>10*ULN) | Calcium, total (<7.5 mg/dL) | Bicarbonate (<=13 mEq/L) | Potassium, serum (>=6 mEqL) | Sodium, serum (<130 mEq/L) | Sodium, serum (>150 mEq/L) | Phosphorus, inorganic (high) | Albumin/creatinine ratio (>1800 mg/g) | Creatinine (>=1.5 preRX creatinine) | |
| Group 1: Dapagliflozin Placebo | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 3 | 0 | 3 | 1 | 1 | 2 | 0 | 0 |
| Group 1: Dapagliflozin, 10 mg AM | 2 | 1 | 4 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 |
| Group 1: Dapagliflozin, 10 mg PM | 4 | 1 | 6 | 0 | 0 | 2 | 1 | 1 | 0 | 1 | 1 | 0 | 2 | 0 | 1 |
| Group 1: Dapagliflozin, 2.5 mg AM | 1 | 0 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 | 1 | 1 |
| Group 1: Dapagliflozin, 2.5 mg PM | 2 | 0 | 2 | 0 | 2 | 1 | 1 | 3 | 0 | 4 | 0 | 1 | 0 | 0 | 1 |
| Group 1: Dapagliflozin, 5 mg AM | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 2 |
| Group 1: Dapagliflozin, 5 mg PM | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 2 | 0 | 1 | 0 | 0 | 3 | 0 | 1 |
| Group 2: Dapagliflozin, 10 mg AM | 4 | 1 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 2 | 0 | 1 |
| Group 2: Dapagliflozin, 5 mg AM | 2 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use (NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | Percentage of change (Mean) |
|---|---|
| Saxagliptin, 5 mg + Insulin | -0.73 |
| Placebo + Insulin | -0.32 |
An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal. (NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | mg/dL (Mean) |
|---|---|
| Saxagliptin, 5 mg + Insulin | -27.2 |
| Placebo + Insulin | -4.2 |
(NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | mg/dL (Mean) |
|---|---|
| Saxagliptin, 5 mg + Insulin | -10.1 |
| Placebo + Insulin | -6.1 |
Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline. (NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | Units (Mean) |
|---|---|
| Saxagliptin, 5 mg + Insulin | 1.71 |
| Placebo + Insulin | 5.01 |
An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal (NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | mg*min/dL (Mean) |
|---|---|
| Saxagliptin, 5 mg + Insulin | -4548.5 |
| Placebo + Insulin | -718.8 |
"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions." (NCT00757588)
Timeframe: Baseline to Week 52
| Intervention | Participants (Number) |
|---|---|
| Saxagliptin, 5 mg + Insulin | 15 |
| Placebo + Insulin | 11 |
Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value. (NCT00757588)
Timeframe: Baseline to Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin, 5 mg + Insulin | 17.3 |
| Placebo + Insulin | 6.7 |
(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52
| Intervention | Beats per minute (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 (n=294, 147) | Week 4 (n=293, 144) | Week 6 (n=280, 141) | Week 8 (n=290, 142) | Week 12 (n=286, 144) | Week 16 (n=278, 139) | Week 20 (n=276, 137) | Week 24 (n=273, 134) | Week 28 (n=264, 132) | Week 36 (n=261, 129) | Week 44 (n=250, 125) | Week 52 (n=246, 125) | |
| Placebo + Insulin | -0.7 | -1.0 | -0.9 | -0.7 | 0.2 | -0.6 | 0.4 | -1.0 | -0.6 | -0.0 | -0.7 | 0.2 |
| Saxagliptin, 5 mg + Insulin | -0.5 | -0.5 | -0.5 | -0.0 | 0.3 | -1.0 | -0.5 | 0.0 | -1.0 | 0.0 | 0.2 | -0.3 |
(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52
| Intervention | mm Hg (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Systolic blood pressure (Week 2) (n=294, 147) | Systolic blood pressure (Week 4) (n=293, 144) | Systolic blood pressure (Week 6) (n=280, 141) | Systolic blood pressure (Week 8) (n=290, 142) | Systolic blood pressure (Week 12) (n=286, 144) | Systolic blood pressure (Week 16) (n=278, 139) | Systolic blood pressure (Week 20) (n=276, 137) | Systolic blood pressure (Week 24) (n=273, 134) | Systolic blood pressure (Week 28) (n=264, 132) | Systolic blood pressure (Week 36) (n=261, 129) | Systolic blood pressure (Week 44) (n=250, 125) | Systolic blood pressure (Week 52) (n=246, 125) | Diastolic blood pressure (Week 2) (n=294, 147) | Diastolic blood pressure (Week 4) (n=293, 144) | Diastolic blood pressure (Week 6) (n=280, 141) | Diastolic blood pressure (Week 8) (n=290, 142) | Diastolic blood pressure (Week 12) (n=286, 144) | Diastolic blood pressure (Week 16) (n=278, 139) | Diastolic blood pressure (Week 20) (n=276, 137) | Diastolic blood pressure (Week 24) (n=273, 134) | Diastolic blood pressure (Week 28) (n=264, 132) | Diastolic blood pressure (Week 36) (n=261, 129) | Diastolic blood pressure (Week 44) (n=250, 125) | Diastolic blood pressure (Week 52) (n=246, 125) | |
| Placebo + Insulin | 2.3 | 0.0 | 1.0 | 2.4 | 2.2 | 1.1 | 1.3 | -0.1 | 1.8 | 3.6 | 2.6 | 1.0 | 1.4 | 1.8 | 0.3 | 2.1 | 1.0 | 1.3 | 1.1 | 0.5 | 0.2 | 0.2 | 0.4 | 0.1 |
| Saxagliptin, 5 mg + Insulin | -1.0 | -1.2 | -0.8 | -0.8 | -1.7 | -1.2 | -0.6 | -1.5 | -1.4 | -0.7 | -0.6 | 0.0 | 0.1 | 0.0 | 0.0 | -0.5 | -0.8 | -1.1 | -0.7 | -1.7 | -1.6 | -1.2 | -0.3 | -0.5 |
An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. (NCT00757588)
Timeframe: Baseline to Week 52, continuously
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| At least 1 AE | At least 1 treatment-related AE | Deaths | At least 1 SAE | At least 1 treatment-related SAE | Discontinuations due to SAEs | Discontinuations due to AEs | |
| Placebo + Insulin | 108 | 34 | 0 | 13 | 0 | 0 | 3 |
| Saxagliptin, 5 mg + Insulin | 202 | 56 | 2 | 25 | 3 | 4 | 9 |
"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4." (NCT00757588)
Timeframe: Baseline and during and up to 14 days after last dose of study drug (in Week 52)
| Intervention | Participants (Number) | |||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin <8 g/dL (n=300; 150) | Hematocrit <0.75*prx (n=300; 150) | Platelets <50*10^9 c/L (n=297; 145) | Platelets >1.5*ULN (n=297; 145) | Leukocytes <2*1000 c/uL (n=300; 150) | Neutrophils <1*1000 c/uL (n=296; 150) | Eosinophils >0.9*1000 c/uL (n=296; 150) | Lymphocytes <=0.75*1000 c/uL (n=296; 150) | Alkaline phosphatase >3*prx & >ULN (n=302; 150) | Alkaline phosphatase >1.5 ULN (n=302; 150) | Aspartate aminotransferase >3* ULN (n=298; 148) | Aspartate aminotransferase>5* ULN (n=298; 148) | Aspartate aminotransferase >10*ULN (n=298; 148) | Aspartate aminotransferase >20*ULN (n=298; 148) | Alanine transaminase >3*ULN (n=300; 148) | Alanine transaminase >5*ULN (n=300; 148) | Alanine transaminase >10*ULN (n=300; 148) | Alanine transaminase >20*ULN (n=300; 148) | Bilirubin, total >2 mg/dL (n=301; 150) | Bilirubin, total >1.5*ULN (n=301; 150) | Bilirubin, total >2*ULN (n=301; 150) | Blood urea nitrogen >2*prx & >ULN (n=302; 150) | Creatinine >2.5 mg/dL (n=303; 150) | Glucose, serum fasting <50 mg/dL (n=0; 0) | Glucose, serum fasting >500 mg/dL (n=0; 0) | Glucose, serum unspecified <50 mg/dL (n=0; 0) | Glucose, serum unspecified >500 mg/dL (n=0; 0) | Glucose, plasma fasting <50 mg/dL (n=301;150) | Glucose, plasma fasting >500 mg/dL (n=301;150) | Glucose, plasma unspecified <50 mg/dL (n=272; 133) | Glucose, plasma unspecified >500 mg/d (n=272; 133) | Sodium, serum <0.9*prx & <=130 mEq/L (n=302; 150) | Sodium, serum >1.1*prx & >=150 mEq/L (n=302; 150) | Potassium, serum <0.8 prx &<=3.2 mEq/L(n=300; 148) | Potassium, serum >1.2*prx&>= 6.0 mEq/L(n=300; 148) | Chloride, serum <90 mEq/L (n=302; 150) | Chloride, serum >120 mEq/L (n=302; 150) | Albumin <0.9*LLN; if prx| Creatine kinase >5*ULN (n=301, 148) | Uric acid >1.5*ULN; if prx >ULN, >2 (n=0,0) | Protein urine (see criteria 1) (n=297,146) | Blood urine (see criteria 1) (n=297; 146) | Red blood cells urine (see criteria 1) (n=53; 31) | White blood cells urine (see criteria 1)(n=115;53) | | |
| Placebo + Insulin | 0 | 2 | 0 | 0 | 1 | 0 | 7 | 2 | 1 | 5 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 1 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 8 | 0 | 0 | 0 | 2 | 0 | 3 | 2 | 3 | 10 |
| Saxagliptin, 5 mg + Insulin | 2 | 2 | 0 | 0 | 0 | 1 | 9 | 3 | 2 | 10 | 2 | 1 | 0 | 0 | 5 | 1 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 5 | 1 | 1 | 0 | 3 | 8 | 1 | 0 | 1 | 6 | 0 | 8 | 14 | 8 | 35 |
Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/ (NCT00757588)
Timeframe: Baseline to Week 52
| Intervention | Percentage of Participants (Number) | |
|---|---|---|
| Reported | Confirmed | |
| Placebo + Insulin | 24.5 | 6.6 |
| Saxagliptin, 5 mg + Insulin | 19.4 | 7.6 |
Absolute lymphocyte count=value*10^3 c/uL (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52
| Intervention | Participants (Number) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline <= 0.75; Week 24 <= 0.75 | Baseline <= 0.75; Week 24 >0.75- <= 5.00 | Baseline <= 0.75; Week 24 >5.00 | Baseline >0.75- <= 5.00; Week 24 <= 0.75 | Baseline >0.75- <= 5.00; Week 24 >0.75- <= 5.00 | Baseline >0.75- <= 5.00; Week 24 >5.00 | Baseline >5.00; Week 24 <= 0.75 | Baseline >5.00; Week 24 >0.75- <= 5.00 | Baseline >5.00; Week 24 >5.00 | Baseline <= 0.75; Week 52 <= 0.75 | Baseline <= 0.75; Week 52 >0.75- <= 5.00 | Baseline <= 0.75; Week 52 >5.00 | Baseline >0.75- <= 5.00; Week 52 <= 0.75 | Baseline >0.75- <= 5.00; Week 52 >0.75- <= 5.00 | Baseline >0.75- <= 5.00; Week 52 >5.00 | Baseline >5.00; Week 52 <= 0.75 | Baseline >5.00; Week 52 >0.75- <= 5.00 | Baseline >5.00; Week 52 >5.00 | |
| Placebo + Insulin | 0 | 2 | 0 | 0 | 148 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 147 | 1 | 0 | 0 | 0 |
| Saxagliptin, 5 mg + Insulin | 0 | 0 | 0 | 1 | 293 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 295 | 0 | 0 | 0 | 1 |
Platelet count=value*10^9 c/L (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52
| Intervention | Participants (Number) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline <= 100; Week 24 <= 100 | Baseline <= 100; Week 24 >100 - <= 600 | Baseline <= 100; Week 24 >600 | Baseline >100 - <= 600; Week 24 <= 100 | Baseline >100 - <= 600; Week 24 >100 - <= 600 | Baseline >100 - <= 600; Week 24 >600 | Baseline >600; Week 24 <= 100 | Baseline >600; Week 24 >100 - <= 600 | Baseline >600; Week 24 >600 | Baseline <= 100; Week 52 <= 100 | Baseline <= 100; Week 52 >100 - <= 600 | Baseline <= 100; Week 52 >600 | Baseline >100 - <= 600; Week 52 <= 100 | Baseline >100 - <= 600; Week 52 >100 - <= 600 | Baseline >100 - <= 600; Week 52 >600 | Baseline >600; Week 52 <= 100 | Baseline >600; Week 52 >100 - <= 600 | Baseline >600; Week 52 >600 | |
| Placebo + Insulin | 0 | 0 | 0 | 1 | 143 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 144 | 0 | 0 | 0 | 0 |
| Saxagliptin, 5 mg + Insulin | 0 | 0 | 0 | 1 | 296 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 295 | 0 | 0 | 0 | 0 |
Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect. (NCT00575588)
Timeframe: Week 24 to Week 104
| Intervention | Percent (Mean) |
|---|---|
| Saxagliptin + Metformin | 0.0041 |
| Glipizide + Metformin | 0.0076 |
Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect. (NCT00575588)
Timeframe: Week 24 to Week 52
| Intervention | Percent (Mean) |
|---|---|
| Saxagliptin + Metformin | 0.001 |
| Glipizide + Metformin | 0.004 |
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set) (NCT00575588)
Timeframe: Baseline, Week 104
| Intervention | Percentage of Participants (Number) |
|---|---|
| Saxagliptin + Metformin | 3.5 |
| Glipizide + Metformin | 38.4 |
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set) (NCT00575588)
Timeframe: From Baseline to Week 52
| Intervention | Percentage of Participants (Number) |
|---|---|
| Saxagliptin + Metformin | 3 |
| Glipizide + Metformin | 36.3 |
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 104
| Intervention | kilograms (Mean) | ||
|---|---|---|---|
| Baseline | Week 104 | Adjusted Change from Baseline to Week 104 | |
| Glipizide + Metformin | 88.57 | 89.80 | 1.29 |
| Saxagliptin + Metformin | 88.69 | 87.47 | -1.47 |
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 52 (Last Observation Carried Forward)
| Intervention | kilogram (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Adjusted Change from Baseline to Week 52 | |
| Glipizide + Metformin | 88.6 | 89.7 | 1.1 |
| Saxagliptin + Metformin | 88.7 | 87.6 | -1.1 |
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 104
| Intervention | Percent (Mean) | ||
|---|---|---|---|
| Baseline | Week 104 | Adjusted Change from Baseline to Week 104 | |
| Glipizide + Metformin | 7.65 | 7.27 | -0.35 |
| Saxagliptin + Metformin | 7.65 | 7.27 | -0.41 |
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value. (NCT00575588)
Timeframe: Baseline to 52 Weeks
| Intervention | Percent (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Adjusted Change from Baseline to Week 52 | |
| Glipizide + Metformin | 7.53 | 6.71 | -0.80 |
| Saxagliptin + Metformin | 7.46 | 6.74 | -0.74 |
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 60.3 |
| Saxagliptin 10 mg + Metformin | 59.7 |
| Metformin | 41.1 |
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 60.3 |
| Saxagliptin 10 mg + Metformin | 59.7 |
| Saxagliptin 10 mg | 32.2 |
Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 45.3 |
| Saxagliptin 10 mg + Metformin | 40.6 |
| Metformin | 29.0 |
Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of Participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 45.3 |
| Saxagliptin 10 mg + Metformin | 40.6 |
| Saxagliptin 10 mg | 20.3 |
Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 7.5 |
| Saxagliptin 10 mg + Metformin | 5.9 |
| Metformin | 10.1 |
Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone. (NCT00327015)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Saxagliptin 5 mg + Metformin | 7.5 |
| Saxagliptin 10 mg + Metformin | 5.9 |
| Saxagliptin 10 mg | 21.2 |
Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | percent (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Metformin | 9.43 | 7.48 | -1.99 |
| Saxagliptin 10 mg + Metformin | 9.53 | 7.02 | -2.49 |
| Saxagliptin 5 mg + Metformin | 9.41 | 6.93 | -2.53 |
Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Metformin | 199.1 | 152.7 | -47.3 |
| Saxagliptin 10 mg + Metformin | 204.3 | 140.1 | -62.2 |
| Saxagliptin 5 mg + Metformin | 198.9 | 140.2 | -59.8 |
Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Saxagliptin 10 mg | 200.9 | 169.9 | -30.9 |
| Saxagliptin 10 mg + Metformin | 204.3 | 140.1 | -62.2 |
| Saxagliptin 5 mg + Metformin | 198.9 | 140.2 | -59.8 |
Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | percent (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Saxagliptin 10 mg | 9.61 | 7.86 | -1.69 |
| Saxagliptin 10 mg + Metformin | 9.53 | 7.02 | -2.49 |
| Saxagliptin 5 mg + Metformin | 9.41 | 6.93 | -2.53 |
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | mg*min/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Metformin | 57937 | 42428 | -15005 |
| Saxagliptin 10 mg + Metformin | 57219 | 35790 | -21336 |
| Saxagliptin 5 mg + Metformin | 55531 | 35324 | -21080 |
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24
| Intervention | mg*min/dL (Mean) | ||
|---|---|---|---|
| Baseline Mean | Week 24 Mean | Adjusted Mean Change from Baseline | |
| Saxagliptin 10 mg | 57584 | 41229 | -16054 |
| Saxagliptin 10 mg + Metformin | 57219 | 35790 | -21336 |
| Saxagliptin 5 mg + Metformin | 55531 | 35324 | -21080 |
To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 24
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo Plus Metformin Plus Sulfonylurea | -0.78 |
| Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | -34.23 |
To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea. (NCT01392677)
Timeframe: Baseline to week 24
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo Plus Metformin Plus Sulfonylurea | -0.17 |
| Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | -0.86 |
To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 8
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo Plus Metformin Plus Sulfonylurea | -0.27 |
| Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | -4.04 |
To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 24
| Intervention | kg (Least Squares Mean) |
|---|---|
| Placebo Plus Metformin Plus Sulfonylurea | -0.58 |
| Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | -2.65 |
To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 24
| Intervention | Percentage of participants (Least Squares Mean) |
|---|---|
| Placebo Plus Metformin Plus Sulfonylurea | 11.1 |
| Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | 31.8 |
(NCT01059825)
Timeframe: Baseline
| Intervention | kg (Mean) |
|---|---|
| Placebo | 83.78 |
| Ertugliflozin 1 mg | 83.44 |
| Ertugliflozin 5 mg | 85.74 |
| Ertugliflozin 10 mg | 82.28 |
| Ertugliflozin 25 mg | 81.81 |
| Sitagliptin 100 mg | 85.52 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. (NCT01059825)
Timeframe: Baseline
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 79.14 |
| Ertugliflozin 1 mg | 78.95 |
| Ertugliflozin 5 mg | 78.19 |
| Ertugliflozin 10 mg | 78.45 |
| Ertugliflozin 25 mg | 78.61 |
| Sitagliptin 100 mg | 79.15 |
Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline
| Intervention | mg/dL (Mean) |
|---|---|
| Placebo | 165.3 |
| Ertugliflozin 1 mg | 162.5 |
| Ertugliflozin 5 mg | 156.5 |
| Ertugliflozin 10 mg | 163.3 |
| Ertugliflozin 25 mg | 171.3 |
| Sitagliptin 100 mg | 166.2 |
HbA1c is measured as percent. (NCT01059825)
Timeframe: Baseline
| Intervention | Percent (Mean) |
|---|---|
| Placebo | 8.08 |
| Ertugliflozin 1 mg | 8.01 |
| Ertugliflozin 5 mg | 7.88 |
| Ertugliflozin 10 mg | 8.13 |
| Ertugliflozin 25 mg | 8.30 |
| Sitagliptin 100 mg | 8.24 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. (NCT01059825)
Timeframe: Baseline
| Intervention | mmHg (Mean) |
|---|---|
| Placebo | 126.7 |
| Ertugliflozin 1 mg | 126.5 |
| Ertugliflozin 5 mg | 127.9 |
| Ertugliflozin 10 mg | 125.8 |
| Ertugliflozin 25 mg | 124.9 |
| Sitagliptin 100 mg | 126.6 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | 0.81 |
| Ertugliflozin 1 mg | -1.12 |
| Ertugliflozin 5 mg | -1.01 |
| Ertugliflozin 10 mg | -3.18 |
| Ertugliflozin 25 mg | -1.83 |
| Sitagliptin 100 mg | 1.68 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -0.57 |
| Ertugliflozin 1 mg | -1.25 |
| Ertugliflozin 5 mg | -1.26 |
| Ertugliflozin 10 mg | -1.97 |
| Ertugliflozin 25 mg | -3.01 |
| Sitagliptin 100 mg | 0.92 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -0.80 |
| Ertugliflozin 1 mg | -2.47 |
| Ertugliflozin 5 mg | -3.08 |
| Ertugliflozin 10 mg | -2.81 |
| Ertugliflozin 25 mg | -2.10 |
| Sitagliptin 100 mg | -0.51 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | 0.80 |
| Ertugliflozin 1 mg | -1.40 |
| Ertugliflozin 5 mg | -0.69 |
| Ertugliflozin 10 mg | -2.23 |
| Ertugliflozin 25 mg | -1.20 |
| Sitagliptin 100 mg | 0.32 |
The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 12
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 2.76 |
| Ertugliflozin 1 mg | -18.23 |
| Ertugliflozin 5 mg | -23.06 |
| Ertugliflozin 10 mg | -31.47 |
| Ertugliflozin 25 mg | -29.26 |
| Sitagliptin 100 mg | -17.29 |
The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 2
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 5.89 |
| Ertugliflozin 1 mg | -15.07 |
| Ertugliflozin 5 mg | -15.68 |
| Ertugliflozin 10 mg | -26.65 |
| Ertugliflozin 25 mg | -16.44 |
| Sitagliptin 100 mg | -14.69 |
The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 4
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 5.17 |
| Ertugliflozin 1 mg | -16.91 |
| Ertugliflozin 5 mg | -22.77 |
| Ertugliflozin 10 mg | -27.95 |
| Ertugliflozin 25 mg | -26.62 |
| Sitagliptin 100 mg | -18.00 |
The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 8
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 3.82 |
| Ertugliflozin 1 mg | -18.25 |
| Ertugliflozin 5 mg | -24.69 |
| Ertugliflozin 10 mg | -31.59 |
| Ertugliflozin 25 mg | -30.99 |
| Sitagliptin 100 mg | -18.93 |
HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]). (NCT01059825)
Timeframe: Baseline and Week 12
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | -0.11 |
| Ertugliflozin 1 mg | -0.56 |
| Ertugliflozin 5 mg | -0.80 |
| Ertugliflozin 10 mg | -0.73 |
| Ertugliflozin 25 mg | -0.83 |
| Sitagliptin 100 mg | -0.87 |
HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | 0.00 |
| Ertugliflozin 1 mg | -0.14 |
| Ertugliflozin 5 mg | -0.29 |
| Ertugliflozin 10 mg | -0.22 |
| Ertugliflozin 25 mg | -0.17 |
| Sitagliptin 100 mg | -0.26 |
HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | -0.04 |
| Ertugliflozin 1 mg | -0.40 |
| Ertugliflozin 5 mg | -0.49 |
| Ertugliflozin 10 mg | -0.48 |
| Ertugliflozin 25 mg | -0.40 |
| Sitagliptin 100 mg | -0.48 |
HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | -0.10 |
| Ertugliflozin 1 mg | -0.57 |
| Ertugliflozin 5 mg | -0.76 |
| Ertugliflozin 10 mg | -0.73 |
| Ertugliflozin 25 mg | -0.75 |
| Sitagliptin 100 mg | -0.77 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -0.55 |
| Ertugliflozin 1 mg | -2.69 |
| Ertugliflozin 5 mg | -4.03 |
| Ertugliflozin 10 mg | -3.43 |
| Ertugliflozin 25 mg | -3.93 |
| Sitagliptin 100 mg | -1.09 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -1.93 |
| Ertugliflozin 1 mg | -2.30 |
| Ertugliflozin 5 mg | -4.73 |
| Ertugliflozin 10 mg | -2.28 |
| Ertugliflozin 25 mg | -5.39 |
| Sitagliptin 100 mg | -0.91 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -2.57 |
| Ertugliflozin 1 mg | -3.94 |
| Ertugliflozin 5 mg | -5.15 |
| Ertugliflozin 10 mg | -5.43 |
| Ertugliflozin 25 mg | -3.33 |
| Sitagliptin 100 mg | -3.32 |
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -0.44 |
| Ertugliflozin 1 mg | -1.53 |
| Ertugliflozin 5 mg | -2.85 |
| Ertugliflozin 10 mg | -3.04 |
| Ertugliflozin 25 mg | -3.30 |
| Sitagliptin 100 mg | -2.43 |
An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication. (NCT01059825)
Timeframe: Up to 84 days
| Intervention | Participants (Number) |
|---|---|
| Placebo | 1 |
| Ertugliflozin 1 mg | 1 |
| Ertugliflozin 5 mg | 3 |
| Ertugliflozin 10 mg | 2 |
| Ertugliflozin 25 mg | 1 |
| Sitagliptin 100 mg | 1 |
| Metformin Run-in | 3 |
An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin. (NCT01059825)
Timeframe: Up to 98 days
| Intervention | Participants (Number) |
|---|---|
| Placebo | 29 |
| Ertugliflozin 1 mg | 31 |
| Ertugliflozin 5 mg | 30 |
| Ertugliflozin 10 mg | 29 |
| Ertugliflozin 25 mg | 28 |
| Sitagliptin 100 mg | 30 |
| Metformin Run-in | 82 |
The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.75 |
| Ertugliflozin 1 mg | -1.90 |
| Ertugliflozin 5 mg | -2.50 |
| Ertugliflozin 10 mg | -2.90 |
| Ertugliflozin 25 mg | -2.66 |
| Sitagliptin 100 mg | -0.30 |
The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.24 |
| Ertugliflozin 1 mg | -0.65 |
| Ertugliflozin 5 mg | -1.36 |
| Ertugliflozin 10 mg | -1.14 |
| Ertugliflozin 25 mg | -1.11 |
| Sitagliptin 100 mg | 0.21 |
The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.44 |
| Ertugliflozin 1 mg | -1.20 |
| Ertugliflozin 5 mg | -1.76 |
| Ertugliflozin 10 mg | -1.68 |
| Ertugliflozin 25 mg | -1.52 |
| Sitagliptin 100 mg | 0.01 |
The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.62 |
| Ertugliflozin 1 mg | -1.65 |
| Ertugliflozin 5 mg | -2.18 |
| Ertugliflozin 10 mg | -2.30 |
| Ertugliflozin 25 mg | -2.40 |
| Sitagliptin 100 mg | -0.38 |
Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Placebo | 6.7 |
| Ertugliflozin 1 mg | 12.0 |
| Ertugliflozin 5 mg | 20.4 |
| Ertugliflozin 10 mg | 13.6 |
| Ertugliflozin 25 mg | 14.9 |
| Sitagliptin 100 mg | 25.5 |
Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Placebo | 15.6 |
| Ertugliflozin 1 mg | 44.0 |
| Ertugliflozin 5 mg | 42.9 |
| Ertugliflozin 10 mg | 38.6 |
| Ertugliflozin 25 mg | 36.2 |
| Sitagliptin 100 mg | 43.1 |
The change in the coefficient of variation (CV) of continuous glucose readings, as assessed by Continuous Glucose Monitoring (CGM) (NCT01524705)
Timeframe: At baseline, 6 months of intervention
| Intervention | percentage (Mean) |
|---|---|
| Insulin Glargine, Metformin, Exenatide | -2.43 |
| Insulin Glargine, Metformin, Prandial Insulin | 0.44 |
% of glycosylated hemoglobin in whole blood at 26 weeks (NCT01524705)
Timeframe: Baseline vs 26 weeks
| Intervention | % of HbA1C (Mean) |
|---|---|
| Insulin Glargine, Metformin, Exenatide | 7.1 |
| Insulin Glargine, Metformin, Prandial Insulin | 7.2 |
Severe hypoglycemia-documented glucose <50mg/dl (participant journal), and hypoglycemic attacks requiring hospitalization, or treatment by emergency personnel. (NCT01524705)
Timeframe: 26 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Insulin Glargine, Metformin, Exenatide | 0 |
| Insulin Glargine, Metformin, Prandial Insulin | 0 |
Weight in kg at 26 weeks minus weight at baseline. (NCT01524705)
Timeframe: Baseline vs 26 weeks
| Intervention | kg (Mean) |
|---|---|
| Insulin Glargine, Metformin, Exenatide | -4.8 |
| Insulin Glargine, Metformin, Prandial Insulin | 0.7 |
"Change from baseline in body weight after 24 weeks.~Note that adjusted means are provided." (NCT01210001)
Timeframe: Baseline and 24 weeks
| Intervention | kg (Mean) |
|---|---|
| Placebo | 0.34 |
| Empa 10mg | -1.62 |
| Empa 25mg | -1.47 |
"Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment.~Note that adjusted means are provided." (NCT01210001)
Timeframe: Baseline and 24 weeks
| Intervention | mg/dL (Mean) |
|---|---|
| Placebo | 6.47 |
| Empa 10mg | -17.00 |
| Empa 25mg | -21.99 |
"Change From Baseline in HbA1c after 24 weeks.~Note that adjusted means are provided." (NCT01210001)
Timeframe: Baseline and 24 weeks
| Intervention | percentage of HbA1c (Mean) |
|---|---|
| Placebo | -0.11 |
| Empa 10mg | -0.59 |
| Empa 25mg | -0.72 |
"Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only.~Note that adjusted means are provided." (NCT01210001)
Timeframe: Baseline and 24 weeks
| Intervention | percentage of HbA1c (Mean) |
|---|---|
| Placebo | -0.11 |
| Empa 10mg | -0.55 |
| Empa 25mg | -0.70 |
Number of patients with hypoglycaemic events, as reported as adverse events. (NCT01210001)
Timeframe: From first drug administration until 7 days after last intake of study drug, up to 256 days
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 1.8 |
| Empa 10mg | 1.2 |
| Empa 25mg | 2.4 |
The estimated mean change in body weight after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26
| Intervention | kg (Mean) |
|---|---|
| Liraglutide | -3.54 |
| Placebo | -0.42 |
The estimated mean change from baseline in FPG after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Liraglutide | -1.44 |
| Placebo | -0.16 |
The estimated mean change from baseline in HbA1c after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26
| Intervention | percentage of glycosylated haemoglobin (Mean) |
|---|---|
| Liraglutide | -1.30 |
| Placebo | -0.11 |
The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment. (NCT01617434)
Timeframe: Week 0 to Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Liraglutide | -2.61 |
| Placebo | -1.02 |
A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL). (NCT01617434)
Timeframe: Week 0 to Week 26 + 7 days follow up
| Intervention | Events/100 years of patient exposure (Number) |
|---|---|
| Liraglutide | 126 |
| Placebo | 83 |
Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions. (NCT01617434)
Timeframe: Week 0 to Week 26 + 7 days follow up
| Intervention | Events/100 years of patient exposure (Number) |
|---|---|
| Liraglutide | 0 |
| Placebo | 0 |
Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment (NCT01617434)
Timeframe: At Week 26
| Intervention | percentage of subjects (Number) |
|---|---|
| Liraglutide | 59.24 |
| Placebo | 14.02 |
Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment. (NCT01617434)
Timeframe: At Week 26
| Intervention | percentage of subjects (Number) |
|---|---|
| Liraglutide | 42.91 |
| Placebo | 3.60 |
An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events. (NCT01617434)
Timeframe: Week 0 to Week 26 + 7 days follow up
| Intervention | Events/1000 years of patient exposure (Number) | ||||
|---|---|---|---|---|---|
| Adverse Events | Serious Adverse Events | Severe Adverse Events | Moderate Adverse Events | Mild Adverse Events | |
| Liraglutide | 4918 | 149 | 169 | 1274 | 3474 |
| Placebo | 3737 | 101 | 101 | 1060 | 2575 |
Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome (NCT01240785)
Timeframe: 5 minutes after delivery
| Intervention | units on a scale (Mean) |
|---|---|
| Metformin | 8.7 |
| Insulin | 8.9 |
birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies (NCT01240785)
Timeframe: delivery
| Intervention | g (Mean) |
|---|---|
| Metformin | 3604 |
| Insulin | 3589 |
(NCT01240785)
Timeframe: delivery
| Intervention | weeks (Mean) |
|---|---|
| Metformin | 39.2 |
| Insulin | 39.3 |
(NCT01240785)
Timeframe: delivery
| Intervention | participants (Number) |
|---|---|
| Metformin | 42 |
| Insulin | 58 |
(NCT01240785)
Timeframe: up to on the average 40 weeks of gestation
| Intervention | kg (Mean) |
|---|---|
| Metformin | 8.0 |
| Insulin | 7.9 |
(NCT01240785)
Timeframe: delivery
| Intervention | no of cesarean section (Number) |
|---|---|
| Metformin | 15 |
| Insulin | 18 |
(NCT01240785)
Timeframe: 0-3 days after delivery
| Intervention | participants (Number) |
|---|---|
| Metformin | 9 |
| Insulin | 10 |
(NCT01240785)
Timeframe: 0-24 h after delivery
| Intervention | participants (Number) |
|---|---|
| Metformin | 18 |
| Insulin | 18 |
(NCT01240785)
Timeframe: 0-5 days after delivery
| Intervention | participants (Number) |
|---|---|
| Metformin | 34 |
| Insulin | 39 |
(NCT01240785)
Timeframe: up to on the average 40 weeks of gestation
| Intervention | participants (Number) |
|---|---|
| Metformin | 5 |
| Insulin | 10 |
Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure > 30 mmHg or diastolic blood pressure > 15 mmHg (NCT01240785)
Timeframe: up to on the average 40 weeks of gestation
| Intervention | participants (Number) |
|---|---|
| Metformin | 2 |
| Insulin | 4 |
(NCT01240785)
Timeframe: delivery
| Intervention | participants (Number) |
|---|---|
| Metformin | 1 |
| Insulin | 2 |
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Canagliflozin 300 mg | -29.9 |
| Sitagliptin 100 mg | -5.85 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Canagliflozin 300 mg | -1.03 |
| Sitagliptin 100 mg | -0.66 |
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Canagliflozin 300 mg | -5.06 |
| Sitagliptin 100 mg | 0.85 |
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 300 mg | -2.5 |
| Sitagliptin 100 mg | 0.3 |
The table below shows the mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 300 mg | 7.6 |
| Sitagliptin 100 mg | 0.6 |
The table below shows the mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 300 mg | 9.6 |
| Sitagliptin 100 mg | 11.9 |
The table below shows the percentage of patients with HbA1c <7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage. (NCT01137812)
Timeframe: Week 52
| Intervention | Percentage of patients (Number) |
|---|---|
| Canagliflozin 300 mg | 47.6 |
| Sitagliptin 100 mg | 35.3 |
The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -118 |
| Canagliflozin 300 mg | -126 |
The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 5.19 |
| Canagliflozin 100 mg | -42.9 |
| Canagliflozin 300 mg | -58.8 |
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -81.7 |
| Canagliflozin 300 mg | -86.3 |
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 8.33 |
| Canagliflozin 100 mg | -27.2 |
| Canagliflozin 300 mg | -35.0 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -2.13 |
| Canagliflozin 300 mg | -2.56 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | 0.14 |
| Canagliflozin 100 mg | -0.77 |
| Canagliflozin 300 mg | -1.03 |
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -4.47 |
| Canagliflozin 300 mg | -4.97 |
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | 0.38 |
| Canagliflozin 100 mg | -3.34 |
| Canagliflozin 300 mg | -5.04 |
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -3.0 |
| Canagliflozin 300 mg | -3.8 |
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.6 |
| Canagliflozin 100 mg | -2.8 |
| Canagliflozin 300 mg | -3.9 |
The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | 2.4 |
| Canagliflozin 300 mg | 10.8 |
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | 4.4 |
| Canagliflozin 100 mg | 11.2 |
| Canagliflozin 300 mg | 10.5 |
The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Canagliflozin 100 mg | -0.6 |
| Canagliflozin 300 mg | -12.7 |
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | 7.8 |
| Canagliflozin 100 mg | 2.5 |
| Canagliflozin 300 mg | -2.4 |
The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Week 26
| Intervention | Percentage of patients (Number) |
|---|---|
| Canagliflozin 100 mg | 17.4 |
| Canagliflozin 300 mg | 11.6 |
The table below shows the percentage of patients with HbA1c <7% at Week 26. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01081834)
Timeframe: Week 26
| Intervention | Percentage of patients (Number) |
|---|---|
| Placebo | 20.6 |
| Canagliflozin 100 mg | 44.5 |
| Canagliflozin 300 mg | 62.4 |
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 4.11 |
| Canagliflozin 100 mg | -18.2 |
| Canagliflozin 300 mg | -30.5 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | -0.13 |
| Canagliflozin 100 mg | -0.85 |
| Canagliflozin 300 mg | -1.06 |
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | -2.65 |
| Canagliflozin 100 mg | -4.89 |
| Canagliflozin 300 mg | -4.27 |
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.7 |
| Canagliflozin 100 mg | -2.1 |
| Canagliflozin 300 mg | -2.6 |
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | 3.2 |
| Canagliflozin 100 mg | 5.7 |
| Canagliflozin 300 mg | 6.5 |
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | 11.6 |
| Canagliflozin 100 mg | 5.4 |
| Canagliflozin 300 mg | 8.5 |
The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01106625)
Timeframe: Week 26
| Intervention | Percentage of patients (Number) |
|---|---|
| Placebo | 18 |
| Canagliflozin 100 mg | 43.2 |
| Canagliflozin 300 mg | 56.6 |
Change in percent body fat (NCT01881828)
Timeframe: 0-26 weeks
| Intervention | percentage of change (Mean) |
|---|---|
| Metformin | -0 |
| Oral Placebo | 1 |
(NCT01881828)
Timeframe: 0-26 weeks
| Intervention | percentile (Mean) |
|---|---|
| Metformin | -1 |
| Oral Placebo | 1 |
(NCT01881828)
Timeframe: 0-26 weeks
| Intervention | insulin per kg (Mean) |
|---|---|
| Metformin | -0.1 |
| Oral Placebo | -0.0 |
(NCT01881828)
Timeframe: 0-26 weeks
| Intervention | centimeters (Mean) |
|---|---|
| Metformin | -0 |
| Oral Placebo | 1 |
(NCT01881828)
Timeframe: 0-26 weeks
| Intervention | mm Hg (Mean) | |
|---|---|---|
| Change in Systolic | Change in Diastolic | |
| Metformin | 0 | 0 |
| Oral Placebo | -0 | 0 |
Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months (NCT01881828)
Timeframe: 0-26 weeks
| Intervention | percentage (Mean) | |
|---|---|---|
| HbA1c | Change from Baseline to 26 Weeks | |
| Metformin | 9.0 | 0.2 |
| Oral Placebo | 8.9 | 0.2 |
Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months (NCT01881828)
Timeframe: 0-26 weeks
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| HbA1c Decrease ≥0.5% | HbA1c Increase ≥0.5% | HbA1c <7.5% | |
| Metformin | 19 | 44 | 3 |
| Oral Placebo | 18 | 35 | 4 |
(NCT01881828)
Timeframe: 0-26 weeks
| Intervention | mg/dL (Mean) | ||||
|---|---|---|---|---|---|
| Change in LDL | Change in VLDL | Change in HDL | Change in Triglycerides | Change in Total Cholesterol | |
| Metformin | -6 | -0 | -0 | 4 | -5 |
| Oral Placebo | 2 | 1 | -1 | 6 | 3 |
The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 7.39 |
| Canagliflozin 100 mg | -18.1 |
| Canagliflozin 300 mg | -20.3 |
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | -0.03 |
| Canagliflozin 100 mg | -0.60 |
| Canagliflozin 300 mg | -0.73 |
Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | 0.00 |
| Canagliflozin 100 mg | -1.03 |
| Canagliflozin 300 mg | -1.18 |
The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Placebo | 1.10 |
| Canagliflozin 100 mg | -3.52 |
| Canagliflozin 300 mg | -6.79 |
Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Placebo | 0.02 |
| Canagliflozin 100 mg | -1.04 |
| Canagliflozin 300 mg | -1.18 |
The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | kg (Least Squares Mean) |
|---|---|
| Placebo | -0.28 |
| Canagliflozin 100 mg | -1.87 |
| Canagliflozin 300 mg | -2.38 |
The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.1 |
| Canagliflozin 100 mg | -2.4 |
| Canagliflozin 300 mg | -3.1 |
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.5 |
| Canagliflozin 100 mg | -0.7 |
| Canagliflozin 300 mg | -0.8 |
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -1.0 |
| Canagliflozin 100 mg | -0.7 |
| Canagliflozin 300 mg | -0.6 |
The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | 1.5 |
| Canagliflozin 100 mg | 6.8 |
| Canagliflozin 300 mg | 6.2 |
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | 0.5 |
| Canagliflozin 100 mg | 0.7 |
| Canagliflozin 300 mg | 0.2 |
The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | -0.5 |
| Canagliflozin 100 mg | -0.9 |
| Canagliflozin 300 mg | -1.0 |
The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Placebo | 7.7 |
| Canagliflozin 100 mg | 2.8 |
| Canagliflozin 300 mg | 8.4 |
The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01106651)
Timeframe: Week 26
| Intervention | Percentage of patients (Number) |
|---|---|
| Placebo | 28.0 |
| Canagliflozin 100 mg | 47.7 |
| Canagliflozin 300 mg | 58.5 |
Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time. (NCT02008682)
Timeframe: Week 0, week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Liraglutide | -2.25 |
| Sitagliptin | -1.36 |
Mean change from baseline in fasting plasma glucose (FPG) at Week 26. (NCT02008682)
Timeframe: Week 0, week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Liraglutide | -2.347 |
| Sitagliptin | -1.205 |
Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. (NCT02008682)
Timeframe: Week 0, week 26
| Intervention | Percent (%) glycosylated haemoglobin (Mean) |
|---|---|
| Liraglutide | -1.666 |
| Sitagliptin | -0.969 |
confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L (NCT02008682)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) |
|---|---|
| Liraglutide | 2 |
| Sitagliptin | 1 |
Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26 (NCT02008682)
Timeframe: After 26 weeks of treatment
| Intervention | percentage of subjects (Number) |
|---|---|
| Liraglutide | 76.5 |
| Sitagliptin | 52.6 |
Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26 (NCT02008682)
Timeframe: After 26 weeks of treatment
| Intervention | percentage of subjects (Number) |
|---|---|
| Liraglutide | 61.7 |
| Sitagliptin | 26.3 |
The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42
| Intervention | Ratio (Mean) |
|---|---|
| Part B-Placebo+Liraglutide | -0.018 |
| Part B-GSK2890457+Liraglutide | -0.009 |
| Part C-Placebo+Metformin | 0.002 |
| Part C-GSK2890457+Metformin | -0.001 |
Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Adjusted mean is reported as LS mean. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42 of Part B and C
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Part B-Placebo+Liraglutide | -0.384 |
| Part B-GSK2890457+Liraglutide | -0.230 |
| Part C-Placebo+Metformin | 0.136 |
| Part C-GSK2890457+Metformin | -0.387 |
Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Adjusted mean is reported as LS mean. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42
| Intervention | Percent of TL hemoglobin (Least Squares Mean) |
|---|---|
| Part B-Placebo+Liraglutide | -0.214 |
| Part B-GSK2890457+Liraglutide | -0.278 |
| Part C-Placebo+Metformin | 0.018 |
| Part C-GSK2890457+Metformin | -0.201 |
HOMA-IR was calculated from the Day -1 and Day 42 fasting glucose and insulin values using dataset generated from the HOMA-2 model. It contained the estimates for HOMA-% insulin sensitivity (S) for pairs of fasting glucose and fasting insulin values. Study data was merged with the HOMA dataset by glucose and insulin. HOMA-IR was calculated as 100/HOMA-%S. HOMA-IR was not determined for any values outside the ranges of plasma glucose 3.5 to 25.0 mmol/L (63 - 450 mg/dL) and plasma insulin 20 to 400 pmol/L. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42
| Intervention | mU*mmol/L^2 (Mean) |
|---|---|
| Part B-Placebo+Liraglutide | -0.150 |
| Part B-GSK2890457+Liraglutide | 0.017 |
The matsuda index was calculated from the Day -1 and Day 42 glucose and insulin results as 10,000 divided by (fasting plasma glucose x fasting plasma insulin x mean glucose at 0-2 hour post-dose x mean insulin at 0-2 hour post dose)^1/2, where glucose was measured in mmol/L and insulin in pmol/L. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42
| Intervention | Deciliter*mL/mg*mU (Mean) |
|---|---|
| Part B-Placebo+Liraglutide | -0.991 |
| Part B-GSK2890457+Liraglutide | -0.602 |
Hypoglycemia is defined as symptoms consistent with hypoglycemia (e.g. dizziness, light-headedness, shakiness) which are confirmed by glucometer measurement of complete blood count (CBG) or plasma glucose value of <50 milligram per deciliter (mg/dL) for Part A or <70 mg/dL for Parts B and C (when possible, CBG values were confirmed with a laboratory measurement). In situations when no glucose sample could be measured at the time of the event, the investigator, at his or her discretion, characterized an event as 'hypoglycemia' based on reported signs and symptoms alone. Healthy participant also had asymptomatic blood glucose values <70 mg/dL as a physiological response to altered food intake (e.g., fasting). (NCT01725126)
Timeframe: Up to Follow-up (8 weeks)
| Intervention | Participants (Count of Participants) |
|---|---|
| Part A-Placebo | 0 |
| Part A-GSK2890457 | 0 |
Hypoglycemia is defined as symptoms consistent with hypoglycemia (e.g. dizziness, light-headedness, shakiness) which are confirmed by glucometer measurement of CBG or plasma glucose value of <50 mg/dL for Part A or <70 mg/dL for Parts B and C (when possible, CBG values were confirmed with a laboratory measurement). In situations when no glucose sample could be measured at the time of the event, the investigator, at his or her discretion, characterized an event as 'hypoglycemia' based on reported signs and symptoms alone. Healthy participant also had asymptomatic blood glucose values <70 mg/dL as a physiological response to altered food intake (e.g., fasting). (NCT01725126)
Timeframe: Up to Follow-up (8 weeks)
| Intervention | Participants (Count of Participants) |
|---|---|
| Part B-Placebo+Liraglutide | 0 |
| Part B-GSK2890457+Liraglutide | 0 |
| Part C-Placebo+Metformin | 0 |
| Part C-GSK2890457+Metformin | 0 |
Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post dose. The AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The analysis population included Liraglutide Pharmacokinetic (PK) Population in Part B comprising of all participants in All Subjects Population for whom a PK sample was obtained and analyzed for Liraglutide. (NCT01725126)
Timeframe: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose
| Intervention | Hour*nanograms/mL (Geometric Mean) | |
|---|---|---|
| Day -1 | Day 42 | |
| Part B-GSK2890457+Liraglutide | 1268.65 | 1265.92 |
| Part B-Placebo+Liraglutide | 2210.15 | 2505.23 |
Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The AUC (0-10 hour) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The analysis population included Metformin PK Population in Part A comprising of all participants in All Subjects Population for whom a PK sample was obtained and analyzed for metformin. (NCT01725126)
Timeframe: Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose
| Intervention | Hour*nanograms/mL (Geometric Mean) | |
|---|---|---|
| Day 1 | Day 42 | |
| Part A-GSK2890457 | 3402.6 | 2231.7 |
| Part A-Placebo | 4346.8 | 5081.9 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | g/L (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Albumin, Day 7 | Albumin, Day 14 | Albumin, Day 28 | Albumin, Day 42 | Total protein, Day 7 | Total protein, Day 14 | Total protein, Day 28 | Total protein, Day 42 | |
| Part A-GSK2890457 | -0.3 | 0.4 | 0.4 | 0.0 | -2.1 | -1.2 | -2.2 | -3.1 |
| Part A-Placebo | 0.0 | 2.0 | 2.5 | 2.5 | -0.8 | -0.3 | 1.0 | 0.8 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | g/L (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Albumin, Day 7 | Albumin, Day 14 | Albumin, Day 28 | Albumin, Day 42 | Total protein, Day 7 | Total protein, Day 14 | Total protein, Day 28 | Total protein, Day 42 | |
| Part B-GSK2890457+Liraglutide | 3.1 | 2.6 | 2.8 | 0.4 | 2.9 | 2.7 | 3.2 | -0.6 |
| Part B-Placebo+Liraglutide | 2.0 | 2.7 | 1.8 | 0.0 | 3.0 | 4.0 | 3.2 | 0.5 |
| Part C-GSK2890457+Metformin | 0.5 | 1.6 | 1.9 | -1.3 | 1.1 | 2.2 | 3.1 | -1.5 |
| Part C-Placebo+Metformin | 1.3 | 0.8 | 2.3 | -0.8 | 1.0 | 1.7 | 2.8 | -0.7 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | International unit per liter (IU/L) (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALP, Day 7 | ALP, Day 14 | ALP, Day 28 | ALP, Day 42 | ALT, Day 7 | ALT, Day 14 | ALT, Day 28 | ALT, Day 42 | AST, Day 7 | AST, Day 14 | AST, Day 28 | AST, Day 42 | GGT, Day 7 | GGT, Day 14 | GGT, Day 28 | GGT, Day 42 | |
| Part A-GSK2890457 | -3.8 | -1.4 | -1.8 | -1.8 | -4.1 | -4.4 | -8.2 | -7.7 | -0.4 | 1.4 | -3.1 | -0.3 | -0.1 | -0.1 | -2.9 | -0.5 |
| Part A-Placebo | -6.0 | -1.3 | 0.0 | -1.0 | 5.5 | 1.3 | 2.0 | 5.3 | 2.3 | -2.3 | -0.8 | 2.3 | 1.5 | 1.0 | 0.8 | 2.5 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | IU/L (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALP, Day 7 | ALP, Day 14 | ALP, Day 28 | ALP, Day 42 | ALT, Day 7 | ALT, Day 14 | ALT, Day 28 | ALT, Day 42 | AST, Day 7 | AST, Day 14 | AST, Day 28 | AST, Day 42 | GGT, Day 7 | GGT, Day 14 | GGT, Day 28 | GGT, Day 42 | |
| Part B-GSK2890457+Liraglutide | 5.5 | 1.8 | 2.8 | 2.2 | -0.1 | 0.6 | 0.9 | 1.0 | 1.1 | 1.9 | 2.2 | 3.8 | -1.2 | -1.4 | 0.8 | 0.2 |
| Part B-Placebo+Liraglutide | 5.3 | 5.2 | -0.3 | 4.3 | -1.3 | -2.3 | -2.5 | -4.3 | -1.2 | -1.3 | -2.0 | -3.8 | 0.7 | 0.8 | 0.0 | -0.7 |
| Part C-GSK2890457+Metformin | -2.2 | -3.7 | -2.5 | -2.8 | -1.0 | -6.3 | -3.8 | -4.2 | 0.2 | -0.3 | 1.4 | 1.9 | 1.3 | 2.3 | 0.5 | -0.9 |
| Part C-Placebo+Metformin | 1.8 | 6.7 | 6.3 | 0.5 | 1.5 | 3.0 | 0.7 | -0.5 | -0.5 | -1.0 | 0.7 | 1.0 | 0.3 | 5.3 | 2.3 | -0.7 |
The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42
| Intervention | Units (U)/L (Mean) | |
|---|---|---|
| Amylase, Day 42 | Lipase, Day 42 | |
| Part B-GSK2890457+Liraglutide | 9.2 | 18.8 |
| Part B-Placebo+Liraglutide | 6.0 | 7.5 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Micromoles (umol)/L (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Direct bilirubin, Day 7 | Direct bilirubin, Day 14 | Direct bilirubin, Day 28 | Direct bilirubin, Day 42 | Total bilirubin, Day 7 | Total bilirubin, Day 14 | Total bilirubin, Day 28 | Total bilirubin, Day 42 | Creatinine, Day 7 | Creatinine, Day 14 | Creatinine, Day 28 | Creatinine, Day 42 | Uric acid, Day 7 | Uric acid, Day 14 | Uric acid, Day 28 | Uric acid, Day 42 | |
| Part A-GSK2890457 | -0.311 | -0.466 | -0.855 | -0.171 | -0.777 | -0.933 | -2.565 | 0.513 | -6.4 | -4.8 | -7.1 | -8.8 | -10.3 | -17.8 | 4.2 | -26.2 |
| Part A-Placebo | 0.000 | 0.428 | -0.428 | -0.855 | 0.000 | 0.428 | 1.283 | 0.855 | 2.2 | -4.4 | 0.0 | -2.2 | -7.4 | -14.9 | -1.5 | -7.4 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | umol/L (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Direct bilirubin, Day 7 | Direct bilirubin, Day 14 | Direct bilirubin, Day 28 | Direct bilirubin, Day 42 | Total bilirubin, Day 7 | Total bilirubin, Day 14 | Total bilirubin, Day 28 | Total bilirubin, Day 42 | Creatinine, Day 7 | Creatinine, Day 14 | Creatinine, Day 28 | Creatinine, Day 42 | Uric acid, Day 7 | Uric acid, Day 14 | Uric acid, Day 28 | Uric acid, Day 42 | |
| Part B-GSK2890457+Liraglutide | -0.208 | -0.305 | -0.197 | -0.197 | -0.855 | -0.611 | 0.132 | 0.263 | 3.0 | 4.2 | 2.0 | -2.4 | 25.1 | 15.3 | 16.9 | 7.8 |
| Part B-Placebo+Liraglutide | 0.542 | 0.314 | 0.513 | 0.599 | 0.570 | -0.570 | -0.000 | -1.425 | 4.6 | -0.1 | 1.9 | -1.0 | 15.9 | -11.9 | 2.0 | -5.0 |
| Part C-GSK2890457+Metformin | -0.200 | -0.185 | -0.014 | -0.328 | 0.000 | 0.285 | 0.998 | -0.428 | 3.4 | 4.6 | 8.2 | -0.8 | 9.9 | 25.3 | 34.7 | 0.5 |
| Part C-Placebo+Metformin | -0.513 | -0.086 | -0.171 | -0.200 | -3.705 | -0.855 | -0.855 | -0.285 | 6.9 | 5.7 | 4.9 | 0.6 | 3.0 | -21.8 | -13.9 | 9.9 |
The electrolytes include calcium, chloride, carbon dioxide content/bicarbonate, potassium, magnesium and sodium. Assessments were done pre-dose at on Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Millimoles (mmol)/L (Mean) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calcium, Day 7 | Calcium, Day 14 | Calcium, Day 28 | Calcium, Day 42 | Chloride, Day 7 | Chloride, Day 14 | Chloride, Day 28 | Chloride, Day 42 | Carbon dioxide/Bicarbonate, Day 7 | Carbon dioxide/Bicarbonate, Day 14 | Carbon dioxide/Bicarbonate, Day 28 | Carbon dioxide/Bicarbonate, Day 42 | Glucose, Day 7 | Glucose, Day 14 | Glucose, Day 28 | Glucose, Day 42 | Potassium, Day 7 | Potassium, Day 14 | Potassium, Day 28 | Potassium, Day 42 | Magnesium, Day 7 | Magnesium, Day 14 | Magnesium, Day 28 | Magnesium, Day 42 | Sodium, Day 7 | Sodium, Day 14 | Sodium, Day 28 | Sodium, Day 42 | Urea/BUN, Day 7 | Urea/BUN, Day 14 | Urea/BUN, Day 28 | Urea/BUN, Day 42 | Phosphorus inorganic, Day 7 | Phosphorus inorganic, Day 14 | Phosphorus inorganic, Day 28 | Phosphorus inorganic, Day 42 | |
| Part A-GSK2890457 | -0.023 | -0.023 | -0.010 | -0.022 | 1.2 | 0.4 | 0.5 | 0.4 | -1.2 | -1.9 | -1.2 | -2.8 | -0.1 | -0.3 | -0.2 | -0.3 | -0.15 | -0.15 | -0.13 | -0.16 | -0.0299 | -0.0486 | -0.0288 | -0.0247 | 0.8 | -0.2 | 1.9 | -0.6 | -0.325 | -0.746 | -0.643 | -0.678 | -0.04 | -0.05 | -0.09 | -0.03 |
| Part A-Placebo | -0.025 | 0.056 | 0.056 | 0.050 | 0.8 | 1.0 | -1.5 | -0.8 | 0.3 | -1.0 | -0.5 | -2.5 | -0.0 | -0.0 | -0.1 | -0.2 | 0.15 | 0.20 | -0.07 | 0.30 | -0.0206 | -0.0617 | -0.0411 | -0.0308 | 0.3 | -0.3 | 1.0 | -1.3 | -0.179 | -0.268 | -0.536 | -0.625 | -0.07 | -0.14 | -0.02 | 0.01 |
The electrolytes include calcium, chloride, carbon dioxide content/bicarbonate, potassium, magnesium and sodium. Assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | mmol/L (Mean) | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calcium, Day 7 | Calcium, Day 14 | Calcium, Day 28 | Calcium, Day 42 | Chloride, Day 7 | Chloride, Day 14 | Chloride, Day 28 | Chloride, Day 42 | Carbon dioxide/Bicarbonate, Day 7 | Carbon dioxide/Bicarbonate, Day 14 | Carbon dioxide/Bicarbonate, Day 28 | Carbon dioxide/Bicarbonate, Day 42 | Glucose, Day 7 | Glucose, Day 14 | Glucose, Day 28 | Glucose, Day 42 | Potassium, Day 7 | Potassium, Day 14 | Potassium, Day 28 | Potassium, Day 42 | Magnesium, Day 7 | Magnesium, Day 14 | Magnesium, Day 28 | Magnesium, Day 42 | Sodium, Day 7 | Sodium, Day 14 | Sodium, Day 28 | Sodium, Day 42 | Urea/BUN, Day 7 | Urea/BUN, Day 14 | Urea/BUN, Day 28 | Urea/BUN, Day 42 | Cholesterol, Day 42 | Phosphorus inorganic, Day 7 | Phosphorus inorganic, Day 14 | Phosphorus inorganic, Day 28 | Phosphorus inorganic, Day 42 | |
| Part B-GSK2890457+Liraglutide | 0.053 | 0.041 | 0.046 | -0.040 | -1.2 | -0.1 | 0.2 | 0.2 | -2.0 | -1.9 | -0.4 | -1.8 | 0.3 | 0.2 | -0.2 | -0.1 | 0.09 | 0.20 | 0.08 | 0.01 | 0.0294 | 0.0176 | 0.0379 | 0.0063 | 0.2 | 1.4 | 1.7 | -0.4 | 0.383 | 0.128 | 0.302 | -0.412 | -0.103 | 0.01 | 0.05 | -0.01 | -0.04 |
| Part B-Placebo+Liraglutide | 0.083 | 0.050 | 0.021 | -0.025 | -1.5 | -0.8 | 0.8 | -1.0 | 0.0 | -1.8 | -1.0 | 0.5 | -0.3 | -0.1 | -0.1 | 0.2 | 0.33 | 0.17 | 0.28 | -0.05 | 0.0206 | -0.0206 | 0.0274 | -0.0137 | 1.2 | 1.3 | 1.8 | 0.5 | -0.000 | -0.297 | 0.119 | -0.595 | -0.853 | 0.10 | 0.01 | 0.06 | 0.01 |
| Part C-GSK2890457+Metformin | -0.004 | 0.017 | 0.035 | -0.056 | 0.4 | 0.6 | 0.3 | 0.3 | -0.6 | -0.7 | -0.3 | -1.3 | -1.7 | -2.2 | -2.0 | 0.1 | 0.06 | 0.07 | -0.07 | 0.08 | -0.0206 | 0.0206 | 0.0240 | -0.0171 | 0.8 | 1.5 | 0.6 | -1.0 | -0.208 | -0.268 | 0.863 | -0.387 | -0.155 | 0.01 | 0.03 | 0.12 | -0.00 |
| Part C-Placebo+Metformin | 0.025 | 0.067 | 0.004 | -0.071 | 0.8 | 0.5 | 1.0 | 0.5 | -2.0 | -2.0 | -2.3 | -2.8 | 0.9 | 0.5 | 1.5 | 1.2 | 0.28 | 0.17 | 0.10 | -0.05 | 0.0206 | 0.0069 | 0.0411 | -0.0274 | 1.3 | 1.5 | 1.0 | -1.0 | 0.179 | 0.178 | 0.714 | -0.655 | -0.052 | -0.03 | -0.10 | -0.12 | -0.05 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Picomoles (pmol)/L (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part A-GSK2890457 | 12.516 | 1.973 | 8.969 | -13.735 |
| Part A-Placebo | -1.256 | 8.072 | -11.659 | -22.721 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | pmol/L (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part B-GSK2890457+Liraglutide | -20.05 | -9.62 | -35.18 | -8.12 |
| Part B-Placebo+Liraglutide | -20.21 | -21.65 | -53.41 | -12.99 |
| Part C-GSK2890457+Metformin | -29.59 | -41.14 | -7.22 | 35.28 |
| Part C-Placebo+Metformin | 45.11 | -79.39 | 34.28 | 34.28 |
The assessments were done pre-dose at Day -1, Day 7 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | Milliunits (mu/L) (Mean) |
|---|---|
| Day 42 | |
| Part B-Placebo+Liraglutide | 0.137 |
| Part C-GSK2890457+Metformin | 0.149 |
| Part C-Placebo+Metformin | -0.187 |
The assessments were done pre-dose at Day -1, Day 7 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | Milliunits (mu/L) (Mean) | |
|---|---|---|
| Day 7 | Day 42 | |
| Part B-GSK2890457+Liraglutide | -5.790 | -0.067 |
The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42
| Intervention | Nanomoles (nmol)/L (Mean) | |
|---|---|---|
| Total thyroxine | Total T3 | |
| Part B-GSK2890457+Liraglutide | 1.0891 | 0.1 |
| Part B-Placebo+Liraglutide | 0.8578 | -0.3 |
| Part C-GSK2890457+Metformin | -2.3597 | -0.2 |
| Part C-Placebo+Metformin | -5.1478 | -0.2 |
Single 12-lead ECGs was obtained after participants rested in a supine position for at least 10 minutes using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QTcB, QTcF and RR intervals. The assessments were done at Day -1 (pre-dose, triplicate), Day 42 (pre-dose) and Follow-up Visit. Baseline value was defined as the average of the triplicate pre-dose assessments done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42 and Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Follow-up (Day 56)
| Intervention | Milliseconds (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PR Interval, Day 42 | PR Interval, Follow-up | QRS Duration, Day 42 | QRS Duration, Follow-up | QT Interval, Day 42 | QT Interval, Follow-up | QTcB, Day 42 | QTcB, Follow-up | QTcF, Day 42 | QTcF, Follow-up | RR Interval, Day 42 | RR Interval, Follow-up | |
| Part B-GSK2890457+Liraglutide | 3.08 | -3.69 | -2.62 | -1.69 | -1.69 | -5.69 | -1.51 | -10.95 | -1.49 | -9.10 | -0.00 | 0.02 |
| Part B-Placebo+Liraglutide | 5.56 | -1.11 | 0.78 | 0.11 | 8.11 | 1.44 | -2.87 | -5.89 | 1.17 | -3.17 | 0.04 | 0.03 |
| Part C-GSK2890457+Metformin | -4.44 | -6.28 | -1.06 | 0.11 | 0.78 | -5.56 | -4.23 | -2.14 | -2.58 | -3.50 | 0.02 | -0.01 |
| Part C-Placebo+Metformin | -6.44 | -3.11 | 0.11 | 0.78 | 2.78 | 0.78 | 0.43 | -3.20 | 1.22 | -1.78 | 0.01 | 0.02 |
Single 12-lead ECGs was obtained after participants rested in a supine position for at least 10 minutes using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QT duration corrected for HR by Fridericia's formula (QTcF) and QT duration corrected for HR by Bazett's formula (QTcB intervals. The assessments were done at Day 1 (pre-dose, triplicate), Day 42 (pre-dose) and Follow-up Visit. Baseline value was defined as the average of the triplicate pre-dose assessments done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42 and Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Follow-up (Day 56)
| Intervention | Milliseconds (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PR Interval, Day 42 | PR Interval, Follow-up | QRS Duration, Day 42 | QRS Duration, Follow-up | QT Interval, Day 42 | QT Interval, Follow-up | QTcB, Day 42 | QTcB, Follow-up | QTcF, Day 42 | QTcF, Follow-up | |
| Part A-GSK2890457 | 1.1 | 1.5 | -2.1 | -0.7 | 16.4 | -10.2 | -3.3 | 6.3 | 3.2 | 0.7 |
| Part A-Placebo | 6.3 | 9.0 | 2.2 | 3.9 | 10.8 | 0.3 | 8.2 | 6.9 | 9.1 | 4.8 |
Two fasting samples 5 minutes apart were taken for insulin. Baseline insulin level was the average of the 2 fasting samples. For insulin weighted mean AUC (0-4 hour) and weighted mean AUC (0-24 hour) was calculated for Baseline (Day -1) and end of treatment (Day 42). AUC was calculated using the linear trapezoid method that is the sum of the areas between each chronological pair of assessments at the time points (at Day -1 and Day 42). The weighted mean was then calculated by dividing the AUC by the length of the time interval over which it was calculated. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data is reported for weighted mean insulin AUC (0-4 hour) post-breakfast and AUC (0-24 hour) post-breakfast. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42
| Intervention | pmol/L (Mean) | ||
|---|---|---|---|
| Fasting Insulin | Insulin Weighted Mean AUC 0-4 hour | Insulin Weighted Mean AUC 0-24 hour | |
| Part B-GSK2890457+Liraglutide | 1.133 | 14.589 | -13.905 |
| Part B-Placebo+Liraglutide | -4.887 | 69.635 | 1.626 |
| Part C-GSK2890457+Metformin | 12.300 | 10.322 | 17.134 |
| Part C-Placebo+Metformin | -11.946 | 57.887 | 22.740 |
The assessments were done at Day -1, Day 7, Day 14, Day 28, Day 42 and Follow-up Visit. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline (Day 7, 14, 28, 42 and Follow-up visit) values. (NCT01725126)
Timeframe: Baseline (Day -1) up to Follow-up (Day 56)
| Intervention | mmol/L (Mean) | ||||
|---|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | Follow-up | |
| Part B-GSK2890457+Liraglutide | 0.285 | 0.210 | -0.201 | -0.098 | 0.444 |
| Part B-Placebo+Liraglutide | -0.278 | -0.093 | -0.111 | 0.194 | 0.962 |
| Part C-GSK2890457+Metformin | -1.665 | -2.216 | -1.989 | 0.074 | -1.226 |
| Part C-Placebo+Metformin | 0.879 | 0.518 | 1.536 | 1.184 | 1.249 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Ratio (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part A-GSK2890457 | -0.0128 | -0.0026 | -0.0066 | -0.0089 |
| Part A-Placebo | 0.0000 | 0.0128 | 0.0228 | 0.0060 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | Ratio (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part B-GSK2890457+Liraglutide | 0.0019 | 0.0011 | -0.0003 | -0.0025 |
| Part B-Placebo+Liraglutide | 0.0032 | -0.0028 | -0.0003 | -0.0022 |
| Part C-GSK2890457+Metformin | -0.0072 | -0.0036 | 0.0003 | -0.0159 |
| Part C-Placebo+Metformin | -0.0082 | 0.0057 | -0.0010 | -0.0087 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | Picograms (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part B-GSK2890457+Liraglutide | -0.21 | -0.10 | 0.01 | 0.08 |
| Part B-Placebo+Liraglutide | -0.02 | 0.18 | 0.17 | -0.12 |
| Part C-GSK2890457+Metformin | -0.18 | 0.03 | -0.08 | 0.02 |
| Part C-Placebo+Metformin | -0.23 | -0.25 | -0.20 | -0.28 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | Femtoliters (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part B-GSK2890457+Liraglutide | 0.39 | 0.54 | 0.55 | 0.07 |
| Part B-Placebo+Liraglutide | 0.35 | 0.02 | 0.05 | -0.90 |
| Part C-GSK2890457+Metformin | 0.25 | 0.76 | 0.17 | -0.27 |
| Part C-Placebo+Metformin | 0.40 | -0.47 | -0.18 | -0.78 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Picograms (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part A-GSK2890457 | 0.31 | 0.32 | 0.37 | 0.89 |
| Part A-Placebo | 0.25 | 0.27 | 0.70 | 1.40 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Femtoliters (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part A-GSK2890457 | -0.55 | 0.95 | -0.62 | 0.35 |
| Part A-Placebo | 0.15 | 0.85 | -0.30 | -0.90 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | GI/L (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Basophils, Day 7 | Basophils, Day 14 | Basophils, Day 28 | Basophils, Day 42 | Eosinophils, Day 7 | Eosinophils, Day 14 | Eosinophils, Day 28 | Eosinophils, Day 42 | Lymphocytes, Day 7 | Lymphocytes, Day 14 | Lymphocytes, Day 28 | Lymphocytes, Day 42 | Monocytes, Day 7 | Monocytes, Day 14 | Monocytes, Day 28 | Monocytes, Day 42 | Total Neutrophils, Day 7 | Total Neutrophils, Day 14 | Total Neutrophils, Day 28 | Total Neutrophils, Day 42 | Platelet count, Day 7 | Platelet count, Day 14 | Platelet count, Day 28 | Platelet count, Day 42 | WBC count, Day 7 | WBC count, Day 14 | WBC count, Day 28 | WBC count, Day 42 | |
| Part B-GSK2890457+Liraglutide | 0.0047 | 0.0041 | 0.0050 | 0.0019 | 0.04 | 0.03 | 0.02 | 0.06 | 0.11 | 0.04 | 0.05 | -0.11 | -0.01 | -0.04 | -0.03 | -0.06 | -0.13 | -0.19 | -0.17 | -0.14 | 8.9 | 7.0 | 10.8 | -13.2 | -0.01 | -0.17 | -0.13 | -0.26 |
| Part B-Placebo+Liraglutide | 0.0270 | 0.0037 | -0.0002 | 0.0098 | 0.02 | 0.01 | 0.01 | 0.01 | 0.31 | 0.18 | 0.08 | 0.02 | 0.04 | -0.05 | 0.03 | 0.00 | 0.27 | 0.38 | -0.01 | -0.24 | 18.3 | 12.8 | 4.5 | -2.0 | 0.65 | 0.52 | 0.08 | -0.20 |
| Part C-GSK2890457+Metformin | -0.0078 | -0.0066 | -0.0068 | -0.0122 | -0.03 | -0.00 | -0.00 | -0.01 | 0.14 | 0.18 | 0.25 | -0.07 | 0.00 | 0.06 | 0.03 | -0.03 | 0.38 | 0.64 | 0.36 | -0.10 | 5.8 | 12.9 | 10.4 | -15.3 | 0.48 | 0.88 | 0.63 | -0.22 |
| Part C-Placebo+Metformin | 0.0047 | -0.0015 | -0.0065 | -0.0190 | -0.01 | -0.02 | 0.01 | -0.02 | 0.09 | 0.08 | 0.05 | -0.11 | 0.01 | 0.06 | 0.06 | -0.00 | -0.54 | -0.27 | -0.48 | -0.50 | 5.0 | 1.2 | 0.5 | -13.8 | -0.43 | -0.13 | -0.35 | -0.62 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Giga cells (GI)/L (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Basophils, Day 7 | Basophils, Day 14 | Basophils, Day 28 | Basophils, Day 42 | Eosinophils, Day 7 | Eosinophils, Day 14 | Eosinophils, Day 28 | Eosinophils, Day 42 | Lymphocytes, Day 7 | Lymphocytes, Day 14 | Lymphocytes, Day 28 | Lymphocytes, Day 42 | Monocytes, Day 7 | Monocytes, Day 14 | Monocytes, Day 28 | Monocytes, Day 42 | Total Neutrophils, Day 7 | Total Neutrophils, Day 14 | Total Neutrophils, Day 28 | Total Neutrophils, Day 42 | Platelet count, Day 7 | Platelet count, Day 14 | Platelet count, Day 28 | Platelet count, Day 42 | WBC count, Day 7 | WBC count, Day 14 | WBC count, Day 28 | WBC count, Day 42 | |
| Part A-GSK2890457 | 0.00 | 0.01 | 0.00 | 0.00 | -0.03 | 0.00 | 0.00 | 0.00 | -0.01 | -0.06 | -0.32 | 0.05 | -0.05 | -0.05 | 0.01 | -0.06 | 0.02 | -0.13 | 0.14 | -0.01 | -1.9 | 3.8 | 9.7 | 3.1 | -0.11 | -0.15 | -0.16 | -0.01 |
| Part A-Placebo | 0.00 | -0.03 | 0.00 | 0.00 | -0.03 | -0.03 | 0.10 | 0.03 | -0.22 | -0.22 | -0.23 | 0.15 | -0.08 | -0.10 | -0.05 | -0.05 | 0.15 | 0.50 | -0.32 | 0.48 | -4.8 | -14.0 | -11.5 | -8.8 | -0.15 | 0.18 | -0.50 | 0.65 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | g/L (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Hemoglobin, Day 7 | Hemoglobin, Day 14 | Hemoglobin, Day 28 | Hemoglobin, Day 42 | MCHC, Day 7 | MCHC, Day 14 | MCHC, Day 28 | MCHC, Day 42 | |
| Part B-GSK2890457+Liraglutide | -1.0 | -1.1 | -1.1 | -0.8 | -4.1 | -3.8 | -1.9 | 0.2 |
| Part B-Placebo+Liraglutide | 0.2 | 0.2 | 0.3 | 0.0 | -2.0 | 2.0 | 1.7 | 2.0 |
| Part C-GSK2890457+Metformin | -3.4 | -2.1 | -0.3 | -4.8 | -2.8 | -2.6 | -1.4 | 0.8 |
| Part C-Placebo+Metformin | -4.3 | 1.7 | -1.2 | -2.8 | -4.5 | -1.2 | -2.0 | -0.2 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | g/L (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Hemoglobin, Day 7 | Hemoglobin, Day 14 | Hemoglobin, Day 28 | Hemoglobin, Day 42 | MCHC, Day 7 | MCHC, Day 14 | MCHC, Day 28 | MCHC, Day 42 | |
| Part A-GSK2890457 | -2.0 | -0.9 | 0.5 | 0.9 | 5.4 | 0.0 | 6.3 | 9.0 |
| Part A-Placebo | 0.8 | 4.0 | 11.3 | 9.8 | 1.8 | -0.5 | 8.5 | 17.5 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | TI/L (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| RBC count, Day 7 | RBC count, Day 14 | RBC count, Day 28 | RBC count, Day 42 | Reticulocytes, Day 7 | Reticulocytes, Day 14 | Reticulocytes, Day 28 | Reticulocytes, Day 42 | |
| Part B-GSK2890457+Liraglutide | 0.004 | -0.011 | -0.023 | -0.031 | -0.0003 | 0.0095 | 0.0035 | 0.0096 |
| Part B-Placebo+Liraglutide | 0.018 | -0.030 | 0.002 | 0.032 | 0.0020 | -0.0019 | 0.0029 | 0.0062 |
| Part C-GSK2890457+Metformin | -0.085 | -0.072 | -0.003 | -0.168 | -0.0015 | 0.0147 | -0.0052 | -0.0042 |
| Part C-Placebo+Metformin | -0.107 | 0.093 | 0.020 | -0.053 | -0.0210 | -0.0286 | -0.0304 | -0.0200 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Trillion cells (TI)/L (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| RBC count, Day 7 | RBC count, Day 14 | RBC count, Day 28 | RBC count, Day 42 | Reticulocytes, Day 7 | Reticulocytes, Day 14 | Reticulocytes, Day 28 | Reticulocytes, Day 42 | |
| Part A-GSK2890457 | -0.116 | -0.084 | -0.045 | -0.115 | 0.0014 | -0.0017 | 0.0071 | 0.0044 |
| Part A-Placebo | -0.008 | 0.090 | 0.258 | 0.107 | 0.0115 | 0.0077 | 0.0073 | 0.0022 |
During the assessment of body weight in the unit, the participant wore lightweight indoor clothing and removed shoes. The assessments were done pre-dose at Day -1, Day 1, Day 7, Day 14, Day 28, Day 42 and Day 43. Baseline value was defined as the average of Day -1 and Day 1 values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. Day 42 value was the average of Day 42 and Day 43 values. (NCT01725126)
Timeframe: Baseline (Day -1 and Day 1) up to Day 42
| Intervention | Kilograms (kg) (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part B-GSK2890457+Liraglutide | 0.20 | 0.05 | 0.47 | -0.39 |
| Part B-Placebo+Liraglutide | -0.12 | 0.37 | 0.15 | -0.74 |
| Part C-GSK2890457+Metformin | 0.47 | 0.56 | 0.27 | 0.42 |
| Part C-Placebo+Metformin | 0.28 | 0.61 | 0.52 | -0.47 |
The impact of GI symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS was the mean of items 1 to 15. Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms and higher scores indicating a lower quality of life with respect to GI symptoms. Baseline was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, 14 and 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Scores on scale (Mean) | ||
|---|---|---|---|
| Day 7 | Day 14 | Day 42 | |
| Part A-GSK2890457 | 0.08 | 0.04 | -0.02 |
| Part A-Placebo | 0.02 | 0.08 | 0.02 |
The impact of GI symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS was the mean of items 1 to 15. Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms and higher scores indicating a lower quality of life with respect to GI symptoms. Baseline was defined as the assessment done on Day -2. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, 14, 28 and 41) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -2) up to Day 41
| Intervention | Scores on scale (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 41 | |
| Part B-GSK2890457+Liraglutide | -0.03 | 0.05 | 0.03 | -0.12 |
| Part B-Placebo+Liraglutide | 0.03 | -0.09 | -0.21 | -0.11 |
| Part C-GSK2890457+Metformin | 0.13 | 0.28 | 0.27 | 0.10 |
| Part C-Placebo+Metformin | 0.24 | 0.20 | 0.14 | 0.02 |
Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Beats per minute (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part A-GSK2890457 | 4.6 | 0.6 | 3.3 | -4.4 |
| Part A-Placebo | 8.0 | 6.3 | 5.5 | -1.3 |
Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | Beats per minute (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part B-GSK2890457+Liraglutide | 0.3 | 0.4 | 3.7 | 1.6 |
| Part B-Placebo+Liraglutide | -3.6 | -3.3 | -7.8 | -4.8 |
| Part C-GSK2890457+Metformin | 1.6 | 3.6 | 1.5 | 0.5 |
| Part C-Placebo+Metformin | 0.1 | 0.8 | 1.8 | -3.2 |
Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day -1) up to Day 42
| Intervention | mmHg (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| SBP, Day 7 | SBP, Day 14 | SBP, Day 28 | SBP, Day 42 | DBP, Day 7 | DBP, Day 14 | DBP, Day 28 | DBP, Day 42 | |
| Part B-GSK2890457+Liraglutide | 2.0 | 3.6 | 0.2 | 0.1 | 0.4 | 0.8 | 0.4 | 0.8 |
| Part B-Placebo+Liraglutide | 1.6 | 5.6 | -0.6 | -2.6 | -2.4 | 2.1 | -3.3 | -1.5 |
| Part C-GSK2890457+Metformin | -3.7 | -2.8 | -7.4 | -3.0 | -0.8 | -2.5 | -3.4 | -3.2 |
| Part C-Placebo+Metformin | 3.2 | 3.2 | 4.5 | 0.0 | 0.9 | -0.8 | -0.4 | 1.1 |
Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. (NCT01725126)
Timeframe: Baseline (Day 1, Randomization) up to Day 42
| Intervention | Millimeters of mercury (mmHg) (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| SBP, Day 7 | SBP, Day 14 | SBP, Day 28 | SBP, Day 42 | DBP, Day 7 | DBP, Day 14 | DBP, Day 28 | DBP, Day 42 | |
| Part A-GSK2890457 | -4.0 | -3.9 | -5.5 | -7.5 | -6.2 | -5.0 | -8.4 | -6.4 |
| Part A-Placebo | 0.8 | -0.5 | -3.3 | -1.0 | -5.3 | -1.8 | -1.3 | -0.8 |
AUC was calculated using the linear trapezoid method that is the sum of the areas between each chronological pair of assessments at the time points (at Day -1 and Day 42). The weighted mean was then calculated by dividing the AUC by the length of the time interval over which it was calculated. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data is reported for weighted mean glucose AUC (0-4 hour) post-breakfast and AUC (0-24 hour) post-breakfast. Adjusted mean is reported as least square (LS) mean. (NCT01725126)
Timeframe: Baseline (Day -1) and Day 42
| Intervention | mmol/L (Least Squares Mean) | |
|---|---|---|
| AUC (0-4 hour) | AUC (0-24 hour) | |
| Part B-GSK2890457+Liraglutide | -0.164 | -0.968 |
| Part B-Placebo+Liraglutide | 0.018 | -0.613 |
| Part C-GSK2890457+Metformin | 0.341 | 0.156 |
| Part C-Placebo+Metformin | 1.194 | 1.376 |
Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The first occurrence of the Cmax was determined directly from the raw concentration-time data. (NCT01725126)
Timeframe: Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose
| Intervention | Nanograms/mL (Geometric Mean) | |
|---|---|---|
| Day 1 | Day 42 | |
| Part A-GSK2890457 | 576.2 | 374.1 |
| Part A-Placebo | 681.8 | 860.1 |
Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The first occurrence of the Cmax was determined directly from the raw concentration-time data. (NCT01725126)
Timeframe: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose
| Intervention | Nanograms/mL (Geometric Mean) | |
|---|---|---|
| Day -1 | Day 42 | |
| Part B-GSK2890457+Liraglutide | 72.24 | 70.86 |
| Part B-Placebo+Liraglutide | 120.00 | 128.57 |
Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessments were done pre-dose on Day 1, Day 7, Day 14, Day 28 and Day 42. (NCT01725126)
Timeframe: up to Day 42
| Intervention | pH (Mean) | ||||
|---|---|---|---|---|---|
| Day 1 | Day 7 | Day 14 | Day 28 | Day 42 | |
| Part A-GSK2890457 | 5.95 | 5.86 | 5.91 | 6.05 | 6.20 |
| Part A-Placebo | 5.25 | 5.88 | 5.50 | 6.13 | 5.63 |
Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessments were done pre-dose on Day -1, Day 7, Day 14, Day 28 and Day 42. (NCT01725126)
Timeframe: Up to Day 42
| Intervention | pH (Mean) | ||||
|---|---|---|---|---|---|
| Day -1 | Day 7 | Day 14 | Day 28 | Day 42 | |
| Part B-GSK2890457+Liraglutide | 6.25 | 5.89 | 6.07 | 5.96 | 6.08 |
| Part B-Placebo+Liraglutide | 5.92 | 5.83 | 5.67 | 5.75 | 6.00 |
| Part C-GSK2890457+Metformin | 5.83 | 5.42 | 5.63 | 5.63 | 5.58 |
| Part C-Placebo+Metformin | 5.67 | 5.83 | 5.67 | 5.67 | 5.58 |
Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were done pre-dose at Da y 1, Day 7, Day 14, Day 28 and Day 42. (NCT01725126)
Timeframe: Up to Day 42
| Intervention | Ratio (Mean) | ||||
|---|---|---|---|---|---|
| Day 1 | Day 7 | Day 14 | Day 28 | Day 42 | |
| Part A-GSK2890457 | 1.0175 | 1.0165 | 1.0152 | 1.0122 | 1.0161 |
| Part A-Placebo | 1.0193 | 1.0133 | 1.0153 | 1.0125 | 1.0155 |
Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. (NCT01725126)
Timeframe: Up to Day 42
| Intervention | Ratio (Mean) | ||||
|---|---|---|---|---|---|
| Day -1 | Day 7 | Day 14 | Day 28 | Day 42 | |
| Part B-GSK2890457+Liraglutide | 1.0174 | 1.0191 | 1.0196 | 1.0239 | 1.0188 |
| Part B-Placebo+Liraglutide | 1.0168 | 1.0208 | 1.0202 | 1.0232 | 1.0137 |
| Part C-GSK2890457+Metformin | 1.0187 | 1.0208 | 1.0201 | 1.0213 | 1.0172 |
| Part C-Placebo+Metformin | 1.0172 | 1.0197 | 1.0198 | 1.0213 | 1.0110 |
The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Only those parameters for which at least one value of abnormal urinalysis result was reported are summarized. The participants were categorized as rare, trace, +1, 2+, RBC's and WBC's as <1, 1, 2, 3 and 4. Protein concentration ranged from trace to 1+, where trace indicated lowest concentration and 1+ indicated highest concentration. Trace was the highest concentration for occult blood. Bacteria concentration ranged from rare to moderate, where rare indicated lowest concentration and moderate indicated highest concentration. Ketones ranged from trace to 1+, where trace indicated lowest concentration and 1+ indicated highest concentration. RBC and WBC ranged from <1 to 4, where <1 indicated lowest concentration and 4 indicated highest concentration. Highest concentration indicated worse outcome. (NCT01725126)
Timeframe: Up to Day 42
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Protein, Trace, Day 1 | Protein, Trace, Day 7 | Protein, 1+, Day 7 | Protein, Trace, Day 14 | Protein, Trace, Day 28 | Protein, Trace, Day 42 | Bacteria, Rare, Day 1 | Bacteria, Rare, Day 42 | Bacteria, Moderate, Day 42 | Occult blood, Trace, Day 1 | Occult blood, Trace, Day 14 | Occult blood, Trace, Day 28 | Ketones, 1+, Day 1 | Ketones, 1+, Day 7 | Ketones, Trace, Day 14 | Ketones, Trace, Day 28 | Ketones, Trace, Day 42 | RBC's, 1, Day 1 | RBC's, 3, Day 1 | RBC's, <1, Day 1 | RBC's, 1, Day 7 | RBC's, <1, Day 7 | RBC's, 2, Day 14 | RBC's, <1, Day 14 | RBC's, 1, Day 28 | RBC's, <1, Day 28 | RBC's, 1, Day 42 | RBC's, 2, Day 42 | RBC's, <1, Day 42 | WBC's, 1, Day 1 | WBC's, <1, Day 1 | WBC's, 1, Day 7 | WBC's, <1, Day 7 | WBC's, 2, Day 14 | WBC's, <1, Day 14 | WBC's, 1, Day 28 | WBC's, <1, Day 28 | WBC's, 1, Day 42 | WBC's, 2, Day 42 | WBC's, 4, Day 42 | |
| Part A-GSK2890457 | 3 | 2 | 1 | 1 | 4 | 2 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 2 | 2 | 2 | 1 | 0 | 1 | 2 | 1 | 2 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 1 |
| Part A-Placebo | 1 | 0 | 0 | 0 | 1 | 2 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 0 | 1 | 1 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Only those parameters for which at least one value of abnormal urinalysis result was reported are summarized. The participants were categorized as few, trace, +1, 2+, 3+, 0-3, 10-20, 0-5, 6-10, and 20-40. Few was the highest concentration of bacteria. Occult blood ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. Epithelial cell ranged from 0-5 to 10-20, 0-5 indicated lowest and 10-20 indicated highest concentration. Glucose ranged from trace to 3+, trace indicated lowest and 3+ indicated highest concentration. 0-5 was highest concentration for hyaline casts. Ketone ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. RBC and WBC ranged from 0-3 to 20-40, 0-3 indicated lowest and 20-40 indicated highest concentration. Highest concentration indicated worse outcome. (NCT01725126)
Timeframe: Up to Day 42
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bacteria, Few, Day -1 | Occult Blood, 1+, Day 14 | Occult Blood, Trace, Day 28 | Occult Blood, Trace, Day 42 | Epithelial Cells, 10-20, Day -1 | Epithelial Cells, 0-5, Day 7 | Epithelial Cells, 6-10, Day 7 | Epithelial Cells, 0-5, Day 14 | Epithelial Cells, 0-5, Day 42 | Glucose, 1+, Day -1 | Glucose, 3+, Day -1 | Glucose, Trace, Day -1 | Glucose, 1+, Day 7 | Glucose, 3+, Day 7 | Glucose, Trace, Day 7 | Glucose, 1+, Day 14 | Glucose, 2+, Day 14 | Glucose, 3+, Day 14 | Glucose, Trace, Day 14 | Glucose, 1+, Day 28 | Glucose, 2+, Day 28 | Glucose, 3+, Day 28 | Glucose, Trace, Day 28 | Glucose, 1+, Day 42 | Glucose, 2+, Day 42 | Glucose, 3+, Day 42 | Glucose, Trace, Day 42 | Hyaline Casts, 0-5, Day 14 | Ketones, 1+, Day 7 | Ketones, Trace, Day 14 | Ketones, Trace, Day 28 | RBC's, 0-3, Day-1 | RBC's, 0-3, Day 7 | RBC's, 0-3, Day 14 | RBC's, 0-3, Day 28 | RBC's, 0-3, Day 42 | WBC's, 20-40, Day -1 | WBC's, 0-5, Day 7 | WBC's, 6-10, Day 7 | WBC's, 0-5, Day 14 | WBC's, 0-5, Day 28 | WBC's, 0-5, Day 42 | |
| Part B-GSK2890457+Liraglutide | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 2 | 1 | 4 | 2 | 1 | 1 | 2 | 3 | 1 | 1 | 1 | 3 | 2 | 1 | 2 | 1 | 0 | 2 | 3 | 3 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 |
| Part B-Placebo+Liraglutide | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 2 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 |
The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. The participants were categorized as few, many, moderate, trace, +1, 2+, 3+, 0-3, 10-20, 0-5, 6-10, 20-40, 40-60. Protein and ketone ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. Bacteria and uric acid crystals ranged from few to moderate, few indicated lowest and moderate indicated highest concentration. Trace was the highest concentration of occult blood. Epithelial cells ranged from 0-5 to >10, 0-5 indicated lowest and >10 indicated highest concentration. Glucose ranged from trace to 3+, trace indicated lowest and 3+ indicated highest concentration. 0-1 was highest concentration for hyaline casts. RBC and WBC ranged from 0-3 to 40-60, 0-3 indicated lowest and 20-40 indicated highest concentration. Highest concentration indicated worse outcome. (NCT01725126)
Timeframe: Up to Day 42
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Protein, 1+, Day 7 | Protein, Trace, Day 7 | Protein, Trace, Day 14 | Protein, 1+, Day 28 | Bacteria, Few, Day -1 | Bacteria, Many, Day -1 | Bacteria, Few, Day 7 | Bacteria, Many, Day 7 | Bacteria, Many, Day 14 | Bacteria, Moderate, Day 14 | Bacteria, Few, Day 28 | Bacteria, Many, Day 28 | Bacteria, Many, Day 42 | Bacteria, Moderate, Day 42 | Occult Blood, Trace, Day 42 | Epithelial Cells, 0-10, Day -1 | Epithelial Cells, 0-10, Day 7 | Epithelial Cells, 0-5, Day 7 | Epithelial Cells, 6-10, Day 7 | Epithelial Cells, 0-5, Day 14 | Epithelial Cells, >10, Day 14 | Epithelial Cells, 0-10, Day 28 | Epithelial Cells, 0-10, Day 42 | Glucose, 1+, Day -1 | Glucose, 2+, Day -1 | Glucose, 3+, Day -1 | Glucose, 1+, Day 7 | Glucose, 2+, Day 7 | Glucose, 3+, Day 7 | Glucose, Trace, Day 7 | Glucose, 1+, Day 14 | Glucose, 3+, Day 14 | Glucose, Trace, Day 14 | Glucose, 2+, Day 28 | Glucose, 3+, Day 28 | Glucose, Trace, Day 28 | Glucose, 1+, Day 42 | Glucose, 2+, Day 42 | Glucose, 3+, Day 42 | Glucose, Trace, Day 42 | Hyaline Casts, 0-1, Day 7 | Ketones, 1+, Day 7 | Ketones, Trace, Day 7 | Ketones, Trace, Day 14 | Ketones, Trace, Day 28 | RBC's, 0-3, Day -1 | RBC's, 0-3, Day 7 | RBC's, 0-3, Day 14 | RBC's, 0-3, Day 28 | RBC's, 0-3, Day 42 | Uric acid crystals, Moderate, Day 7 | Uric acid crystals, Few, Day 14 | WBC's, 0-5, Day -1 | WBC's, 0-5, Day 7 | WBC's, 6-10, Day 7 | WBC's, 0-5, Day 14 | WBC's, 0-5, Day 28 | WBC's, 40-60, Day 28 | WBC's, 6-10, Day 42 | |
| Part C-GSK2890457+Metformin | 1 | 2 | 1 | 1 | 1 | 0 | 4 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 6 | 0 | 2 | 1 | 2 | 2 | 2 | 4 | 2 | 1 | 2 | 2 | 1 | 4 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 3 | 1 | 2 | 1 | 0 | 1 |
| Part C-Placebo+Metformin | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 1 |
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. (NCT01725126)
Timeframe: Up to Follow-up (8 weeks)
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Any AE | Any SAE | Any Death | |
| Part A-GSK2890457 | 10 | 0 | 0 |
| Part A-Placebo | 3 | 0 | 0 |
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as ALT >=3 x ULN, and total bilirubin >=2 x ULN or international normalized ratio >1.5. (NCT01725126)
Timeframe: Up to Follow-up (8 weeks)
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Any AE | Any SAE | Any Death | |
| Part B-GSK2890457+Liraglutide | 3 | 0 | 0 |
| Part B-Placebo+Liraglutide | 1 | 0 | 0 |
| Part C-GSK2890457+Metformin | 3 | 0 | 0 |
| Part C-Placebo+Metformin | 3 | 0 | 0 |
During the assessment of body weight in the unit, the participant wore lightweight indoor clothing and removed shoes. The assessments were done pre-dose at Day -1, Day 1, Day 7, Day 14, Day 28, Day 42 and Day 43. Baseline value was defined as the average of Day -1 and Day 1 values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. Percent change was calculated by multiplying the change from Baseline value with 100. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. Day 42 value was the average of Day 42 and Day 43 values. (NCT01725126)
Timeframe: Baseline (Day -1 and Day 1) up to Day 42
| Intervention | Percent change (Mean) | |||
|---|---|---|---|---|
| Day 7 | Day 14 | Day 28 | Day 42 | |
| Part B-GSK2890457+Liraglutide | 0.18 | -0.04 | 0.39 | -0.51 |
| Part B-Placebo+Liraglutide | -0.16 | 0.47 | 0.25 | -0.80 |
| Part C-GSK2890457+Metformin | 0.59 | 0.60 | 0.30 | 0.50 |
| Part C-Placebo+Metformin | 0.36 | 0.79 | 0.66 | -0.53 |
Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The time at which Cmax was observed was determined directly from the raw concentration-time data. (NCT01725126)
Timeframe: Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose
| Intervention | Hours (Median) | |
|---|---|---|
| Day -1 | Day 42 | |
| Part B-GSK2890457+Liraglutide | 8.00 | 9.98 |
| Part B-Placebo+Liraglutide | 9.74 | 9.92 |
Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The time at which Cmax was observed was determined directly from the raw concentration-time data. (NCT01725126)
Timeframe: Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose
| Intervention | Hours (Median) | |
|---|---|---|
| Day 1 | Day 42 | |
| Part A-GSK2890457 | 2.000 | 2.000 |
| Part A-Placebo | 3.010 | 4.000 |
Body mass index (BMI) measured in kg per meters squared. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. (NCT00081328)
Timeframe: 24 months
| Intervention | kg per meters squared (Mean) |
|---|---|
| 1 Metformin Alone | 36.7 |
| 2 Metformin + Rosliglitazone | 38.2 |
| 3 Metformin + Lifestyle Program | 35.3 |
Measured by DXA, both whole body scan and AP-spine scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan. (NCT00081328)
Timeframe: 24 months
| Intervention | g/cm squared (Mean) |
|---|---|
| 1 Metformin Alone | 1.15 |
| 2 Metformin + Rosliglitazone | 1.15 |
| 3 Metformin + Lifestyle Program | 1.15 |
Determined by DXA whole body scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan. (NCT00081328)
Timeframe: 24 months
| Intervention | kg (Mean) |
|---|---|
| 1 Metformin Alone | 36.1 |
| 2 Metformin + Rosliglitazone | 39.7 |
| 3 Metformin + Lifestyle Program | 32.2 |
Waist circumference (cm) measured at the iliac crest at its outermost point with the measuring tape placed around the participant in a horizontal plane parallel to the floor at the mark and the measurement teken at the end of normal expiration without the tape compressing the skin. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. (NCT00081328)
Timeframe: 24 months
| Intervention | cm (Mean) |
|---|---|
| 1 Metformin Alone | 110.8 |
| 2 Metformin + Rosliglitazone | 114.0 |
| 3 Metformin + Lifestyle Program | 108.6 |
A diagnosis was made by an out-of-range value >=95th percentile or systolic >=130 or diastolic >=80 sustained over 6 months or on an anti-hypertensive medication. (NCT00081328)
Timeframe: Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.
| Intervention | participants (Number) |
|---|---|
| 1 Metformin Alone | 57 |
| 2 Metformin + Rosliglitazone | 53 |
| 3 Metformin + Lifestyle Program | 45 |
A diagnosis was made from out-of-range value >= 130 mg/dL sustained over 6 months or put on lipid lowering medication. (NCT00081328)
Timeframe: Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.
| Intervention | participants (Number) |
|---|---|
| 1 Metformin Alone | 18 |
| 2 Metformin + Rosliglitazone | 16 |
| 3 Metformin + Lifestyle Program | 15 |
A diagnosis was made by an out-of-range value >=150 mg/dL sustained over 6 months or on appropriate lipid lowering medication. (NCT00081328)
Timeframe: Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.
| Intervention | participants (Number) |
|---|---|
| 1 Metformin Alone | 20 |
| 2 Metformin + Rosliglitazone | 28 |
| 3 Metformin + Lifestyle Program | 22 |
Insulinogenic index determined from OGTT as difference in insulin at 30 minutes minus 0 minutes divided by difference in glucose at 30 minutes minus 0 minutes. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. (NCT00081328)
Timeframe: 24 months
| Intervention | uU/mL divided by mg/dL (Median) |
|---|---|
| 1 Metformin Alone | .75 |
| 2 Metformin + Rosliglitazone | .83 |
| 3 Metformin + Lifestyle Program | .71 |
All participants were followed to 24 months. Insulin sensitivity is measured from OGTT as inverse of fasting insulin (mL/uU). The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. (NCT00081328)
Timeframe: 24 months
| Intervention | mL/uU (Median) |
|---|---|
| 1 Metformin Alone | 0.037 |
| 2 Metformin + Rosiglitazone | 0.049 |
| 3 Metformin + Lifestyle Program | 0.039 |
Number of serious adverse events reported during the trial. Participant could have multiple episodes reported. (NCT00081328)
Timeframe: Reported as occurred during study follow-up - 2 years to 6.5 years from randomization.
| Intervention | episodes of serious adverse event (Number) |
|---|---|
| 1 Metformin Alone | 42 |
| 2 Metformin + Rosiglitazone | 34 |
| 3 Metformin + Lifestyle Program | 58 |
Defined as A1c persistently >=8% over a 6-month period or persistent metabolic decompensation (inability to wean insulin within 3 months of initiation or the occurrence of a second episode within three months of discontinuing insulin) (NCT00081328)
Timeframe: Study duration - 2 years to 6.5 years of follow up from randomization
| Intervention | participants (Number) | |
|---|---|---|
| Treatment failure | Did not fail treatment during trial | |
| 1 Metformin Alone | 120 | 112 |
| 2 Metformin + Rosliglitazone | 90 | 143 |
| 3 Metformin + Lifestyle Program | 109 | 125 |
Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lixisenatide | -0.784 |
| Insulin Glulisine QD | -0.782 |
| Insulin Glulisine TID | -1.053 |
"Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.~Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug." (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | kg (Least Squares Mean) |
|---|---|
| Lixisenatide | -0.63 |
| Insulin Glulisine QD | 1.03 |
| Insulin Glulisine TID | 1.37 |
Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lixisenatide | -0.23 |
| Insulin Glulisine QD | -0.21 |
| Insulin Glulisine TID | -0.06 |
Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Lixisenatide | -3.42 |
| Insulin Glulisine QD | -1.59 |
| Insulin Glulisine TID | -1.56 |
Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | percentage of hemoglobin (Least Squares Mean) |
|---|---|
| Lixisenatide | -0.63 |
| Insulin Glulisine QD | -0.58 |
| Insulin Glulisine TID | -0.84 |
Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | U (Least Squares Mean) |
|---|---|
| Lixisenatide | 0.7 |
| Insulin Glulisine QD | -0.06 |
| Insulin Glulisine TID | -3.13 |
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. (NCT01768559)
Timeframe: Baseline, Week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Lixisenatide | -3.93 |
| Insulin Glulisine QD | -1.62 |
| Insulin Glulisine TID | -1.87 |
The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF. (NCT01768559)
Timeframe: Week 26
| Intervention | U (Mean) |
|---|---|
| Insulin Glulisine QD | 9.97 |
| Insulin Glulisine TID | 20.24 |
The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. (NCT01768559)
Timeframe: Week 26
| Intervention | percentage of participants (Number) |
|---|---|
| Lixisenatide | 31.2 |
| Insulin Glulisine QD | 16.7 |
| Insulin Glulisine TID | 17.6 |
The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. (NCT01768559)
Timeframe: Week 26
| Intervention | percentage of participants (Number) |
|---|---|
| Lixisenatide | 29.4 |
| Insulin Glulisine QD | 24.2 |
| Insulin Glulisine TID | 26.1 |
The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data. (NCT01768559)
Timeframe: Week 26
| Intervention | percentage of participants (Number) |
|---|---|
| Lixisenatide | 22.2 |
| Insulin Glulisine QD | 9.2 |
| Insulin Glulisine TID | 10.8 |
The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug. (NCT01768559)
Timeframe: Week 26
| Intervention | percentage of participants (Number) |
|---|---|
| Lixisenatide | 64.7 |
| Insulin Glulisine QD | 36.6 |
| Insulin Glulisine TID | 30.5 |
"The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.~The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9." (NCT01768559)
Timeframe: Week 26
| Intervention | U (Mean) |
|---|---|
| Insulin Glulisine QD | 73.61 |
| Insulin Glulisine TID | 81.05 |
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. (NCT01768559)
Timeframe: First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Documented symptomatic hypoglycemia | Severe symptomatic hypoglycemia | |
| Insulin Glulisine QD | 37.5 | 0.7 |
| Insulin Glulisine TID | 44.6 | 0 |
| Lixisenatide | 31.5 | 0 |
The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF. (NCT01768559)
Timeframe: Week 26
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HbA1c ≤6.5% | HbA1c <7.0% | |
| Insulin Glulisine QD | 17.8 | 38.4 |
| Insulin Glulisine TID | 30.8 | 49.2 |
| Lixisenatide | 20.5 | 42.1 |
Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline) (NCT00993187)
Timeframe: Baseline and Week 30
| Intervention | kg (Least Squares Mean) |
|---|---|
| Sitagliptin/Metformin | -0.83 |
| Glimepiride | 0.90 |
Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline). (NCT00993187)
Timeframe: Baseline and Week 30
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Sitagliptin/Metformin | -47.0 |
| Glimepiride | -23.5 |
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline). (NCT00993187)
Timeframe: Baseline and Week 30
| Intervention | Percent of total hemoglobin (Least Squares Mean) |
|---|---|
| Sitagliptin/Metformin | -1.5 |
| Glimepiride | -0.7 |
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product. (NCT00993187)
Timeframe: Up to 30 weeks
| Intervention | Participants (Number) |
|---|---|
| Sitagliptin/Metformin | 8 |
| Glimepiride | 8 |
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product. (NCT00993187)
Timeframe: Up to 32 weeks
| Intervention | Participants (Number) |
|---|---|
| Sitagliptin/Metformin | 88 |
| Glimepiride | 101 |
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). (NCT00993187)
Timeframe: Week 30
| Intervention | Percentage of Participants (Number) |
|---|---|
| Sitagliptin/Metformin | 81.2 |
| Glimepiride | 40.1 |
Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required. (NCT00993187)
Timeframe: Up to Week 30
| Intervention | Percentage of participants (Number) |
|---|---|
| Sitagliptin/Metformin | 5.5 |
| Glimepiride | 20.1 |
Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Week 24
| Intervention | Units (U) (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 36.08 |
| Insulin Glargine | 39.32 |
2-hour plasma glucose excursion = 2-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -3.91 |
| Insulin Glargine | -0.67 |
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -7.49 |
| Insulin Glargine | -4.33 |
Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, over a single day, once in a week before baseline, before visit Week 12 and before visit Week 24 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -3.23 |
| Insulin Glargine | -2.93 |
Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 3 days after the last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | kg (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -0.97 |
| Insulin Glargine | 0.48 |
Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 1 day after the last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -3.35 |
| Insulin Glargine | -3.51 |
Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP). (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | percentage of hemoglobin (Least Squares Mean) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -1.82 |
| Insulin Glargine | -1.64 |
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one documented symptomatic hypoglycemia before the introduction of rescue medication and up to 1 day after the last injection of IMP. Otherwise, they were counted as missing data. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP. (NCT01476475)
Timeframe: Baseline up to Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 67.5 |
| Insulin Glargine | 59.0 |
Participants without any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (for HbA1c and body weight) was available and showed non-response. Otherwise, they were counted as missing data. (NCT01476475)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 56.3 |
| Insulin Glargine | 37.3 |
Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceed the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%. (NCT01476475)
Timeframe: Baseline up to Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 0 |
| Insulin Glargine | 0.6 |
30-minute and 1-hour plasma glucose excursion = 30-minute and 1-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) | |
|---|---|---|
| 30-minute plasma glucose excursion (n=151, 152) | 1-hour plasma glucose excursion (n=150, 152) | |
| Insulin Glargine | -0.05 | -0.44 |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -1.47 | -2.34 |
The 30 minute and 1-hour PPG test measured blood glucose 30 minutes and 1-hour after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP. (NCT01476475)
Timeframe: Baseline, Week 24
| Intervention | mmol/L (Least Squares Mean) | |
|---|---|---|
| 30-minute PPG (n=151, 153) | 1-hour PPG (n=150, 153) | |
| Insulin Glargine | -3.76 | -4.10 |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | -5.01 | -5.94 |
Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes were associated with sufficient neuroglycopenia to induce seizure, unconsciousness or coma. All episodes in which neurological impairment was severe enough to prevent self-treatment and which were thought to place participants at risk for injury to themselves or others. (NCT01476475)
Timeframe: First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Documented symptomatic hypoglycemia | Severe Symptomatic Hypoglycemia | |
| Insulin Glargine (Lantus® SoloSTAR®) | 22.8 | 0.0 |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 21.7 | 0.0 |
On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP. (NCT01476475)
Timeframe: Week 24
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HbA1c ≤6.5% | HbA1c <7.0% | |
| Insulin Glargine | 64.6 | 78.3 |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination | 71.9 | 84.4 |
Change from baseline in body weight after 26 weeks of treatment. (NCT01973231)
Timeframe: Week 0, week 26
| Intervention | kg (Mean) |
|---|---|
| Liraglutide | -4.24 |
| Lixisenatide | -3.69 |
Change from baseline in FPG after 26 weeks of treatment. (NCT01973231)
Timeframe: Week 0, week 26
| Intervention | mmol/L (Mean) |
|---|---|
| Liraglutide | -2.904 |
| Lixisenatide | -1.644 |
Change from baseline in HbA1c after 26 weeks of treatment. (NCT01973231)
Timeframe: Week 0, week 26
| Intervention | Percent (%) glycosylated haemoglobin (Mean) |
|---|---|
| Liraglutide | -1.809 |
| Lixisenatide | -1.238 |
A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator. (NCT01973231)
Timeframe: Weeks 0-26
| Intervention | events (Number) | ||||
|---|---|---|---|---|---|
| Events | Serious | Severe | Moderate | Mild | |
| Liraglutide | 540 | 13 | 10 | 109 | 421 |
| Lixisenatide | 435 | 7 | 3 | 84 | 348 |
Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no). (NCT01973231)
Timeframe: After 26 weeks of treatment
| Intervention | percentage (%) of subjects (Number) | |
|---|---|---|
| Yes | No | |
| Liraglutide | 74.2 | 25.8 |
| Lixisenatide | 45.5 | 54.5 |
Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no). (NCT01973231)
Timeframe: After 26 weeks of treatment
| Intervention | percentage (%) of subjects (Number) | |
|---|---|---|
| Yes | No | |
| Liraglutide | 66.5 | 33.5 |
| Lixisenatide | 41.9 | 58.1 |
Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no). (NCT01973231)
Timeframe: After 26 weeks of treatment
| Intervention | percentage (%) of subjects (Number) | |
|---|---|---|
| Yes | No | |
| Liraglutide | 54.6 | 45.4 |
| Lixisenatide | 26.2 | 73.8 |
Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: From baseline to week 26
| Intervention | kg (Mean) |
|---|---|
| Liraglutide | -3.32 |
| Sitagliptin | -1.80 |
Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: From baseline to week 26
| Intervention | nmol/L (Mean) |
|---|---|
| Liraglutide | -1.967 |
| Sitagliptin | -0.588 |
Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM). (NCT01907854)
Timeframe: From baseline to week 26
| Intervention | percentage of glycosylated haemoglobin (Mean) |
|---|---|
| Liraglutide | -1.146 |
| Sitagliptin | -0.529 |
A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period. (NCT01907854)
Timeframe: During 26 weeks of treatment plus one week follow-up period.
| Intervention | number of events (Number) |
|---|---|
| Liraglutide | 455 |
| Sitagliptin | 318 |
Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein [LDL], very low density lipoprotein [VLDL], high density lipoprotein [HDL], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data. (NCT01907854)
Timeframe: From baseline to week 26
| Intervention | ratio (Mean) | |||||
|---|---|---|---|---|---|---|
| Total cholesterol | LDL cholesterol | VLDL cholesterol | HDL cholesterol | Triglycerides | Free Fatty acids | |
| Liraglutide | 1.011 | 1.049 | 1.062 | 1.004 | 1.089 | 1.086 |
| Sitagliptin | 1.045 | 1.121 | 1.075 | 0.997 | 1.099 | 1.104 |
Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: From baseline to week 26
| Intervention | mmHg (Mean) | |
|---|---|---|
| Systolic Blood Pressure | Diastolic Blood Pressure | |
| Liraglutide | -3.6 | -0.23 |
| Sitagliptin | -2.57 | -0.81 |
Number of subjects who achieve HbA1c <7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM. (NCT01907854)
Timeframe: After 26 weeks of treatment
| Intervention | percentage (%) (Number) | |
|---|---|---|
| Yes | No | |
| Liraglutide | 50.6 | 49.4 |
| Sitagliptin | 26.9 | 73.1 |
Change in dense breast volume at 12 months (NCT02028221)
Timeframe: Baseline, 12 months
| Intervention | cm^3 (Mean) |
|---|---|
| Placebo | -12.11 |
| Metformin | -14.75 |
change of dense breast volume at 6 months (NCT02028221)
Timeframe: baseline, 6 months
| Intervention | cm^3 (Mean) |
|---|---|
| Placebo | -5.45 |
| Metformin | -13.71 |
(NCT02028221)
Timeframe: baseline, 6 months, 12 months
| Intervention | kg (Mean) | ||
|---|---|---|---|
| Baseline | 6 months | 12 months | |
| Metformin | 101.5 | 99.6 | 99.3 |
| Placebo | 102.3 | 102.1 | 103.2 |
(NCT02028221)
Timeframe: baseline, 6 months, 12 months
| Intervention | data presented as ratio; no unit (Mean) | ||
|---|---|---|---|
| Baseline | 6 months | 12 months | |
| Metformin | 0.170 | 0.169 | 0.165 |
| Placebo | 0.178 | 0.178 | 0.171 |
(NCT02028221)
Timeframe: baseline, 6 months, 12 months
| Intervention | uIU/ml (Mean) | ||
|---|---|---|---|
| Baseline | 6 months | 12 months | |
| Metformin | 13.5 | 11.9 | 11.7 |
| Placebo | 14.6 | 14.0 | 13.1 |
(NCT02028221)
Timeframe: baseline, 6 months, 12 months
| Intervention | data presented as ratio; no unit (Mean) | ||
|---|---|---|---|
| Baseline | 6 months | 12 months | |
| Metformin | 0.028 | 0.025 | 0.026 |
| Placebo | 0.023 | 0.022 | 0.021 |
(NCT02028221)
Timeframe: baseline, 6 months, 12 months
| Intervention | cm (Mean) | ||
|---|---|---|---|
| Baseline | 6 months | 12 months | |
| Metformin | 111.2 | 108.9 | 108.3 |
| Placebo | 110.3 | 111.6 | 111.8 |
Area under the concentration-time curve of Empa in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). (NCT01276288)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 5 with EMPA alone and on Day 9 with EMPA plus diuretic. The Pre-dose values were averaged over Days 1 to 4 with EMPA alone and on Days 7 & 8 with EMPA plus diuretic
| Intervention | nmol*h/L (Geometric Mean) |
|---|---|
| Empagliflozin (Empa) | 4990 |
| Empa+ HCT | 5570 |
| Empa + TOR | 5260 |
Area under the concentration-time curve of HCT in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). (NCT01276288)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with HCT alone and on Day 9 with EMPA plus HCT. The Pre-dose values were averaged over Days 1 to 3 with HCT alone and on Days 7 & 8 with EMPA plus HCT
| Intervention | ng*h/mL (Geometric Mean) |
|---|---|
| Hydrochlorothiazide (HCT) | 1040 |
| HCT+ Empa | 1000 |
Area under the concentration-time curve of TOR in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). (NCT01276288)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with TOR alone and on Day 9 with EMPA plus TOR. The Pre-dose values were averaged over Days 1 to 3 with TOR alone and on Days 7 & 8 with EMPA plus TOR
| Intervention | ng*h/mL (Geometric Mean) |
|---|---|
| Torasemide (TOR) | 1320 |
| TOR+ Empa | 1340 |
| TOR Metabolite (TOR-M1) | 74.8 |
| TOR Metabolite (TOR-M3) | 40.5 |
| TOR-M1+ Empa | 78.1 |
| TOR-M3 + Empa | 41.8 |
"Change in body weight from baseline , where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | kg (Mean) |
|---|---|
| Empagliflozin (Empa) | -1.365 |
| Hydrochlorothiazide (HCT) | -1.040 |
| Torasemide (TOR) | -0.380 |
| Empa+ HCT | -2.030 |
| Empa + TOR | -1.750 |
"Change in pH in capillary or arterialised blood from baseline, where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | pH (Mean) |
|---|---|
| Empagliflozin (Empa) | -0.006 |
| Hydrochlorothiazide (HCT) | 0.003 |
| Torasemide (TOR) | -0.002 |
| Empa+ HCT | 0.008 |
| Empa + TOR | -0.005 |
"Change in serum concentration of Aldosterone from baseline , where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | nmol/L (Mean) |
|---|---|
| Empagliflozin (Empa) | -0.018 |
| Hydrochlorothiazide (HCT) | 0.099 |
| Torasemide (TOR) | 0.023 |
| Empa+ HCT | 0.124 |
| Empa + TOR | 0.123 |
"Change in serum concentration of ALP from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | U/L (Mean) |
|---|---|
| Empagliflozin (Empa) | 2.750 |
| Hydrochlorothiazide (HCT) | 3.000 |
| Torasemide (TOR) | 2.400 |
| Empa+ HCT | 6.500 |
| Empa + TOR | 5.800 |
"Change in serum concentration of fibroblast growth factor-23 (FGF- 23) from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline, The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | RU/mL (Mean) |
|---|---|
| Empagliflozin (Empa) | 50.305 |
| Hydrochlorothiazide (HCT) | 29.050 |
| Torasemide (TOR) | -0.680 |
| Empa+ HCT | 109.860 |
| Empa + TOR | 13.820 |
"Changes in serum osmolality from baseline based on a blood sample.~Baseline was defined as the measurement obtained before the first drug administration in the first period.~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | mOsm/Kg (Mean) |
|---|---|
| Empagliflozin (Empa) | 3.950 |
| Hydrochlorothiazide (HCT) | -7.500 |
| Torasemide (TOR) | -5.500 |
| Empa+ HCT | -2.200 |
| Empa + TOR | 10.500 |
"Change in urea concentration in urine from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | mmol/L (Mean) |
|---|---|
| Empagliflozin (Empa) | -1.515 |
| Hydrochlorothiazide (HCT) | 67.570 |
| Torasemide (TOR) | 35.710 |
| Empa+ HCT | 11.780 |
| Empa + TOR | 48.690 |
"Change in urinary excretion in a 24-hour period of N-terminal telopeptide (NTx) from baseline, where baseline was defined as the value obtained from the last 24-hour (h) collection period before the first drug administration in the first treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: 24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT
| Intervention | nM BCE/ mMC (Mean) |
|---|---|
| Empagliflozin (Empa) | 6.010 |
| Hydrochlorothiazide (HCT) | 0.730 |
| Torasemide (TOR) | 2.030 |
| Empa+ HCT | 1.380 |
| Empa + TOR | 3.900 |
"Change from baseline in urinary weight in a 24 hour (h)- collection period, where baseline is the last 24-h collection period before first trial drug administration in each treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: 24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT
| Intervention | g/day (Mean) |
|---|---|
| Empagliflozin (Empa) | 134.700 |
| Hydrochlorothiazide (HCT) | -55.300 |
| Torasemide (TOR) | -39.000 |
| Empa+ HCT | 429.000 |
| Empa + TOR | 353.200 |
"Change in urine osmolality from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | mOsm/kg (Mean) |
|---|---|
| Empagliflozin (Empa) | 223.15 |
| Hydrochlorothiazide (HCT) | -3.900 |
| Torasemide (TOR) | -5.800 |
| Empa+ HCT | 217.700 |
| Empa + TOR | 330.400 |
"Change in urine pH from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | pH (Mean) |
|---|---|
| Empagliflozin (Empa) | -0.132 |
| Hydrochlorothiazide (HCT) | -0.452 |
| Torasemide (TOR) | -0.147 |
| Empa+ HCT | -0.448 |
| Empa + TOR | 0.130 |
Maximum measured concentration of Empa in plasma (Cmax, ss) at steady state (NCT01276288)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 5 with EMPA alone and on Day 9 with EMPA plus diuretic. The Pre-dose values were averaged over Days 1 to 4 with EMPA alone and on Days 7 & 8 with EMPA plus diuretic
| Intervention | nmol/L (Geometric Mean) |
|---|---|
| Empagliflozin (Empa) | 939 |
| Empa+ HCT | 1030 |
| Empa + TOR | 949 |
Maximum measured concentration of HCT in plasma (Cmax, ss) at steady state (NCT01276288)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with HCT alone and on Day 9 with EMPA plus HCT. The Pre-dose values were averaged over Days 1 to 3 with HCT alone and on Days 7 & 8 with EMPA plus HCT
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| Hydrochlorothiazide (HCT) | 203 |
| HCT+ Empa | 205 |
Maximum measured concentration of Empa in plasma (Cmax, ss) at steady state (NCT01276288)
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with TOR alone and on Day 9 with EMPA plus TOR. The Pre-dose values were averaged over Days 1 to 3 with TOR alone and on Days 7 & 8 with EMPA plus TOR
| Intervention | ng/mL (Geometric Mean) |
|---|---|
| Torasemide (TOR) | 710 |
| TOR+ Empa | 741 |
| TOR Metabolite (TOR-M1) | 42.6 |
| TOR Metabolite (TOR-M3) | 8.58 |
| TOR-M1+ Empa | 43.8 |
| TOR-M3 + Empa | 8.79 |
"Number of subjects with clinical relevant abnormalities in vital signs (blood pressure, pulse rate), 12-lead resting electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis, and monitoring of fasting plasma glucose), physical examination and assessment of tolerability by the investigator.~New abnormal findings were reported as Adverse Events (AE). Only Alanine aminotransferase normal under system organ class investigations was determined as an existing AE." (NCT01276288)
Timeframe: From first drug administration until up to 14 days after the last drug administration, up to 35 days
| Intervention | participants (Number) |
|---|---|
| Empagliflozin (Empa) | 1 |
| Hydrochlorothiazide (HCT) | 0 |
| Torasemide (TOR) | 0 |
| Empa+ HCT | 0 |
| Empa + TOR | 0 |
For this endpoint the change in total micturition frequency from the baseline was only examined for EMPA where baseline was defined as the day before the first drug administration. (NCT01276288)
Timeframe: Baseline and day 5
| Intervention | voids per day (Mean) |
|---|---|
| Empagliflozin (Empa) | 1.600 |
The change in total Muscle sympathetic nerve activity (MSNA) that represents an area under the curve of all C-fiber action potentials per minute. This endpoint was evaluated only for Empa. For this endpoint a baseline value was not defined. However, the parameters obtained at 2 measurements time points during the trial were compared. (NCT01276288)
Timeframe: One day before the drug administration, then day 4 after the first drug administration
| Intervention | action potentials per min (Mean) |
|---|---|
| Empagliflozin (Empa) | 0.241 |
"Change in clearance of sodium, potassium, creatinine, magnesium, chloride,calcium, phosphate and uric acid from baseline, where baseline is defined as the value obtained from the last 24-h collection period before the first drug administration in the first treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: 24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT
| Intervention | ml/min (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Sodium | Chloride | Potassium | Magnesium | Calcium | Phosphate | Uric Acid | Creatinine | |
| Empa + TOR | -0.004 | -0.117 | 2.324 | 0.209 | -0.174 | 2.359 | 4.359 | -11.768 |
| Empa+ HCT | 0.143 | 0.114 | 4.125 | 1.115 | -0.407 | 2.795 | 5.065 | -10.126 |
| Empagliflozin (Empa) | -0.031 | -0.129 | 2.040 | 0.398 | -0.326 | 5.275 | 6.377 | 3.167 |
| Hydrochlorothiazide (HCT) | -0.055 | -0.058 | 2.205 | 1.826 | -0.299 | 4.633 | -0.476 | -7.034 |
| Torasemide (TOR) | -0.071 | -0.157 | -0.518 | 1.148 | -0.065 | 4.368 | -1.310 | -4.250 |
"Change in serum concentration of Creatinine and Uric acid from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT
| Intervention | umol/L (Mean) | |
|---|---|---|
| Creatinine | Uric acid | |
| Empa + TOR | 3.570 | -48.200 |
| Empa+ HCT | 6.280 | -31.000 |
| Empagliflozin (Empa) | 2.175 | -64.950 |
| Hydrochlorothiazide (HCT) | -0.340 | 24.200 |
| Torasemide (TOR) | -2.180 | -4.700 |
"Change in serum concentration of Renin, intact parathyroid hormone (iPTH) and 1,25-dihydroxyvitamin D from baseline , where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | pg/mL (Mean) | ||
|---|---|---|---|
| Renin | iPTH | 1,25-dihydroxyvitamin D | |
| Empa + TOR | 17.050 | 12.190 | -0.970 |
| Empa+ HCT | 32.760 | 9.280 | -5.060 |
| Empagliflozin (Empa) | -0.960 | 8.265 | 0.230 |
| Hydrochlorothiazide (HCT) | 16.150 | 6.160 | 1.560 |
| Torasemide (TOR) | 2.550 | 6.910 | 3.530 |
"Change in serum concentration of sodium, potassium, magnesium, calcium, chloride, phosphate, glucose and urea from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | mmol/L (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Sodium | Potassium | Magnesium | Chloride | Calcium | Phosphate | Urea | Glucose | |
| Empa + TOR | 1.600 | -0.360 | 0.145 | 2.100 | -0.060 | 0.050 | 2.122 | -0.526 |
| Empa+ HCT | -0.100 | -0.530 | 0.130 | -3.200 | -0.010 | 0.170 | 1.504 | -0.033 |
| Empagliflozin (Empa) | 1.500 | -0.170 | 0.139 | 2.050 | -0.055 | 0.045 | 0.710 | -1.123 |
| Hydrochlorothiazide (HCT) | -0.500 | -0.470 | 0.025 | -2.600 | -0.040 | 0.060 | 0.650 | 0.849 |
| Torasemide (TOR) | 0.200 | -0.200 | 0.059 | 1.000 | -0.080 | -0.060 | 0.318 | 0.527 |
"Change in urinary excretion in a 24-hour period of sodium, potassium, magnesium, chloride, calcium, phosphate, creatinine, uric acid, glucose from baseline, where baseline was defined as the value obtained from the last 24-hour (h) collection period before the first drug administration in the first treatment period. This applies also to sodium excretion in urine, which is additionally obtained one day before the drug administration before the second period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: 24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT
| Intervention | mmol/day (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Sodium | Chloride | Potassium | Magnesium | Calcium | Phosphate | Creatinine | Uric acid | Glucose | |
| Empa + TOR | 1.200 | -14.600 | 8.460 | 1.050 | -0.740 | 5.000 | -0.040 | 1.244 | 740.910 |
| Empa+ HCT | 28.900 | 11.400 | 15.790 | 2.030 | -1.360 | 8.300 | 0.022 | 1.555 | 685.233 |
| Empagliflozin (Empa) | -4.300 | -16.300 | 10.370 | 1.190 | -1.160 | 9.250 | 0.091 | 1.641 | 599.449 |
| Hydrochlorothiazide (HCT) | -11.700 | -12.300 | 6.200 | 2.270 | -1.020 | 9.000 | -0.078 | -0.037 | 17.584 |
| Torasemide (TOR) | -13.700 | -22.000 | -6.990 | 1.720 | -0.430 | 4.900 | -0.073 | -0.500 | 17.932 |
"Changes in bicarbonate concentrations of calcium, bicarbonate ions and base excess in capillary or arterialised blood from baseline, where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa" (NCT01276288)
Timeframe: baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT
| Intervention | mmol/ L (Mean) | ||
|---|---|---|---|
| Bicarbonate concentrations of calcium | bicarbonate ions | Base excess | |
| Empa + TOR | -1.590 | -0.049 | -1.450 |
| Empa+ HCT | 1.860 | -0.053 | 1.720 |
| Empagliflozin (Empa) | -1.090 | -0.049 | -1.045 |
| Hydrochlorothiazide (HCT) | 2.020 | -0.043 | 1.640 |
| Torasemide (TOR) | -0.400 | -0.041 | -0.420 |
Urinary sodium excretion over 24-hour run-in periods to assess the harmonisation of electrolytes after intake of a standardised diet (NCT01276288)
Timeframe: Day 3, 2 and 1 before the first drug administration
| Intervention | mmol/day (Mean) | ||
|---|---|---|---|
| 3 days before the drug administration | 2 days before the drug administration | 1 day before the drug administration | |
| Empagliflozin (Empa) | 198.50 | 174.35 | 163.90 |
| Hydrochlorothiazide (HCT) | 211.10 | 183.30 | 170.10 |
| Torasemide (TOR) | 217.90 | 178.70 | 179.10 |
IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG | 181 |
| Combined MET/SU | 188 |
Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG | 50 |
| Combined MET/SU | 63 |
All deaths identified during the original record study and discovered after the re-adjudication efforts began were included. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG | 139 |
| Combined MET/SU | 160 |
The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG | 88 |
| Combined MET/SU | 96 |
"The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as unknown deaths, but were counted as CV deaths for the analysis of this endpoint." (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG | 88 |
| Combined MET/SU | 96 |
Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG | 186 |
| Combined MET/SU | 191 |
The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG | 72 |
| Combined MET/SU | 62 |
The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme >= 2x the ULN or CK > 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG | 68 |
| Combined MET/SU | 60 |
The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG | 53 |
| Combined MET/SU | 64 |
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
| Intervention | U/L (Units/Liter) (Mean) |
|---|---|
| RSG in Addition to Background MET | -37.43 |
| SU in Addition to Background MET | -21.73 |
| RSG in Addition to Background SU | -30.17 |
| MET in Addition to Background SU | -24.00 |
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
| Intervention | kilograms (Mean) |
|---|---|
| RSG in Addition to Background MET | 3.93 |
| SU in Addition to Background MET | -0.54 |
| RSG in Addition to Background SU | 4.72 |
| MET in Addition to Background SU | -2.16 |
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period
| Intervention | mmol/L (millimoles/Liter) (Mean) |
|---|---|
| RSG in Addition to Background MET | -1.38 |
| SU in Addition to Background MET | -0.29 |
| RSG in Addition to Background SU | -2.00 |
| MET in Addition to Background SU | -0.94 |
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline and Month 60 of randomised dual therapy treatment period
| Intervention | Percent (Mean) |
|---|---|
| RSG in Addition to Background MET | -0.14 |
| SU in Addition to Background MET | 0.17 |
| RSG in Addition to Background SU | -0.24 |
| MET in Addition to Background SU | -0.10 |
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
| Intervention | cm (centimeters) (Mean) |
|---|---|
| RSG in Addition to Background MET | 2.70 |
| SU in Addition to Background MET | 0.65 |
| RSG in Addition to Background SU | 3.00 |
| MET in Addition to Background SU | -0.60 |
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period
| Intervention | percent change (Geometric Mean) |
|---|---|
| RSG in Addition to Background MET | -13.77 |
| SU in Addition to Background MET | -11.63 |
| RSG in Addition to Background SU | -9.68 |
| MET in Addition to Background SU | -12.09 |
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
| Intervention | percent change (Geometric Mean) |
|---|---|
| RSG in Addition to Background MET | -57.40 |
| SU in Addition to Background MET | -28.92 |
| RSG in Addition to Background SU | -56.50 |
| MET in Addition to Background SU | -36.29 |
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
| Intervention | percent change (Geometric Mean) |
|---|---|
| RSG in Addition to Background MET | 2.12 |
| SU in Addition to Background MET | 5.74 |
| RSG in Addition to Background SU | -0.23 |
| MET in Addition to Background SU | 3.14 |
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
| Intervention | percent change (Geometric Mean) |
|---|---|
| RSG in Addition to Background MET | -9.85 |
| SU in Addition to Background MET | 15.01 |
| RSG in Addition to Background SU | -7.79 |
| MET in Addition to Background SU | -0.64 |
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
| Intervention | percent change (Geometric Mean) |
|---|---|
| RSG in Addition to Background MET | 8.31 |
| SU in Addition to Background MET | 15.17 |
| RSG in Addition to Background SU | -3.43 |
| MET in Addition to Background SU | 11.91 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG: Main Study and Observational Follow-up | 0 |
| Combined MET/SU: Main Study and Observational Follow-up | 0 |
The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| Combined RSG | 321 |
| Combined MET/SU | 323 |
Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | partcipants (Number) |
|---|---|
| RSG in Addition to Background MET | 158 |
| SU in Addition to Background MET | 154 |
| RSG in Addition to Background SU | 163 |
| MET in Addition to Background SU | 169 |
Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started. (NCT00379769)
Timeframe: Baseline through to end of randomised dual therapy
| Intervention | participants (Number) |
|---|---|
| RSG in Addition to Background MET | 281 |
| SU in Addition to Background MET | 451 |
| RSG in Addition to Background SU | 365 |
| MET in Addition to Background SU | 424 |
The number of participants starting insulin at any time during the study was recorded. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) |
|---|---|
| RSG in Addition to Background MET | 126 |
| SU in Addition to Background MET | 276 |
| RSG in Addition to Background SU | 168 |
| MET in Addition to Background SU | 259 |
Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
| Intervention | mmHg (millimeters of mercury) (Mean) | |
|---|---|---|
| SBP | DBP | |
| MET in Addition to Background SU | -0.6 | -2.3 |
| RSG in Addition to Background MET | -1.9 | -3.6 |
| RSG in Addition to Background SU | -2.3 | -3.6 |
| SU in Addition to Background MET | -2.2 | -3.4 |
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value. (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period
| Intervention | picamoles/liter (pmol/L) (Mean) | |
|---|---|---|
| Insulin, Adjusted Change from Baseline | Pro-insulin, Adjusted Change from Baseline | |
| MET in Addition to Background SU | -12.1 | -3.0 |
| RSG in Addition to Background MET | -18.6 | -2.4 |
| RSG in Addition to Background SU | -16.9 | -3.2 |
| SU in Addition to Background MET | 3.7 | 4.2 |
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
| Intervention | percent change (Geometric Mean) | ||||
|---|---|---|---|---|---|
| Total cholesterol | HDL-cholesterol | LDL-cholesterol | Triglycerides | Free fatty acids | |
| MET in Addition to Background SU | -9.68 | 6.14 | -17.80 | -2.50 | 4.47 |
| RSG in Addition to Background MET | -5.49 | 9.95 | -12.70 | -7.97 | -16.46 |
| RSG in Addition to Background SU | -2.91 | 7.73 | -8.99 | -2.68 | -11.58 |
| SU in Addition to Background MET | -9.09 | 2.57 | -17.68 | -1.95 | 2.79 |
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period
| Intervention | percent change (Geometric Mean) | |
|---|---|---|
| Total Cholesterol: HDL Cholesterol Ratio | LDL Cholesterol: HDL-Cholesterol Ratio | |
| MET in Addition to Background SU | -15.01 | -22.53 |
| RSG in Addition to Background MET | -14.20 | -20.89 |
| RSG in Addition to Background SU | -9.93 | -15.85 |
| SU in Addition to Background MET | -11.33 | -20.04 |
The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]). (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment phase
| Intervention | percent change (Geometric Mean) | |
|---|---|---|
| Beta cell function | Insulin sensitivity | |
| MET in Addition to Background SU | 12.43 | 23.90 |
| RSG in Addition to Background MET | 20.54 | 42.57 |
| RSG in Addition to Background SU | 32.35 | 42.07 |
| SU in Addition to Background MET | 19.28 | -3.45 |
"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable." (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | bone fracture events (Number) | |||||
|---|---|---|---|---|---|---|
| Number of bone fracture events | Unknown | Normal healing with standard management | Complication | Additional therapeutic measures required | Data unavailable | |
| Combined MET/SU: Main Study and Observational Follow-up | 174 | 5 | 142 | 13 | 9 | 5 |
| Combined RSG: Main Study and Observational Follow-up | 299 | 7 | 250 | 14 | 16 | 12 |
"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable." (NCT00379769)
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
| Intervention | bone fracture events (Number) | |||||
|---|---|---|---|---|---|---|
| Number of bone fracture events | Unknown | Normal healing with standard management | Complication | Additional therapeutic measures required | Data unavailable | |
| Combined MET/SU: Observational Follow-up | 41 | 1 | 33 | 4 | 2 | 1 |
| Combined RSG: Observational Follow-up | 70 | 1 | 51 | 7 | 3 | 8 |
Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L) (NCT00379769)
Timeframe: Baseline to Month 60 of the randomised dual therapy treatment period
| Intervention | participants (Number) | |
|---|---|---|
| HbA1c Responders | FPG Responders | |
| MET in Addition to Background SU | 180 | 154 |
| RSG in Addition to Background MET | 265 | 300 |
| RSG in Addition to Background SU | 235 | 257 |
| SU in Addition to Background MET | 208 | 180 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE. (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any cancer-related death | Any gastrointestinal event | Pancreatic | Colon/rectal | Gastric | Liver | Gall bladder/biliary | Gastrointestinal event; not specified | Any genitourinary event | Renal | Uterine | Prostate | Bladder | Ovarian | Lung | Any hematologic event | Skin (melanoma) | Skin (non-melanomatous) | Metastases | Breast | Head and neck | Any neurologic event | Endocrine | Not specified | |
| Combined MET/SU: Main Study and Observational Follow-up | 72 | 34 | 12 | 11 | 3 | 4 | 3 | 1 | 15 | 3 | 5 | 2 | 3 | 2 | 11 | 0 | 0 | 0 | 4 | 3 | 2 | 2 | 0 | 1 |
| Combined RSG: Main Study and Observational Follow-up | 59 | 25 | 4 | 6 | 7 | 4 | 4 | 0 | 6 | 2 | 1 | 1 | 1 | 1 | 13 | 4 | 3 | 1 | 2 | 2 | 1 | 2 | 1 | 0 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE. (NCT00379769)
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
| Intervention | participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any cancer-related death | Any gastrointestinal event | Pancreatic | Colon/rectal | Gastric | Liver | Gall bladder/biliary | Gastrointestinal event; not specified | Any genitourinary event | Renal | Uterine | Prostate | Bladder | Ovarian | Lung | Any hematologic event | Skin (melanoma) | Skin (non-melanomatous) | Metastases | Breast | Head and neck | Any neurologic event | Endocrine | Not specified | |
| Combined MET/SU: Observational Follow-up | 24 | 14 | 3 | 6 | 1 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 1 | 3 | 0 | 1 | 0 | 0 |
| Combined RSG: Observational Follow-up | 25 | 10 | 3 | 2 | 2 | 2 | 1 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 4 | 4 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | participants (Number) | ||
|---|---|---|---|
| Overall, n=2220, 2227 | Male, n=1142, 1152 | Female, n=1078, 1075 | |
| Combined MET/SU: Main Study and Observational Follow-up | 151 | 60 | 91 |
| Combined RSG: Main Study and Observational Follow-up | 238 | 82 | 156 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. (NCT00379769)
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
| Intervention | participants (Number) | ||
|---|---|---|---|
| Overall, n=1280, 1250 | Male, n=665, 635 | Female, n=615, 615 | |
| Combined MET/SU: Observational Follow-up | 37 | 11 | 26 |
| Combined RSG: Observational Follow-up | 64 | 25 | 39 |
The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE. (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Any event | Upper limb | Distal lower limb | Femur/hip | Spinal | Pelvic | Other | |
| Combined MET/SU: Main Study and Observational Follow-up | 57 | 17 | 16 | 11 | 9 | 3 | 4 |
| Combined RSG: Main Study and Observational Follow-up | 81 | 41 | 24 | 15 | 7 | 0 | 7 |
The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE. (NCT00379769)
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Any event | Upper limb | Distal lower limb | Femur/hip | Spinal | Pelvic | Other | |
| Combined MET/SU: Observational Follow-up | 21 | 5 | 8 | 4 | 3 | 1 | 1 |
| Combined RSG: Observational Follow-up | 35 | 17 | 9 | 6 | 2 | 0 | 2 |
The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) | ||
|---|---|---|---|
| Participants with an event | First Event - Triple Therapy | First Event - Insulin | |
| MET in Addition to Background SU | 171 | 6 | 165 |
| RSG in Addition to Background MET | 295 | 257 | 38 |
| RSG in Addition to Background SU | 344 | 296 | 49 |
| SU in Addition to Background MET | 183 | 7 | 176 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Any event | Non-traumatic event | Traumatic event | Pathologic | Unknown | Data unavailable | |
| Combined MET/SU: Main Study and Observational Follow-up | 151 | 55 | 77 | 4 | 19 | 3 |
| Combined RSG: Main Study and Observational Follow-up | 238 | 113 | 110 | 1 | 20 | 9 |
"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable." (NCT00379769)
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Any event | Non-traumatic event, | Traumatic event | Pathologic | Unknown | Data unavailable | |
| Combined MET/SU: Observational Follow-up | 37 | 14 | 17 | 2 | 4 | 1 |
| Combined RSG: Observational Follow-up | 64 | 36 | 24 | 1 | 1 | 3 |
Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| CV death, acute MI, stroke | CV death, acute MI, stroke, unstable angina | CV death, acute MI, stroke, unstable angina, CHF | All-cause death,acuteMI,stroke,unstable angina,CHF | Acute MI (fatal or non-fatal) | Stroke (fatal or non-fatal) | CHF (fatal or non-fatal) | Death from CV causes | Death (all cause) during CV follow-up | Death (all-cause) including survival status | |
| Combined MET/SU | 165 | 184 | 206 | 268 | 56 | 63 | 29 | 71 | 139 | 157 |
| Combined RSG | 154 | 171 | 204 | 251 | 64 | 46 | 61 | 60 | 111 | 136 |
The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants with a CV/Microvascular event | Participants with any microvascular event | Participants with any eye event | Participants with any foot event | Participants with any renal event | |
| Combined MET/SU | 385 | 78 | 52 | 28 | 0 |
| Combined RSG | 363 | 59 | 42 | 19 | 0 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown). (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Any H/UA/FF event, overall, n=2220, 2227 | Any H/UA/FF event, male, n=1142, 1152 | Any H/UA/FF event, female, n=1078, 1075 | High morbidity fractures, overall, n=2220, 2227 | High morbidity fractures, male, n=1142, 1152 | High morbidity fractures, female, n=1078, 1075 | Non-high morbidity fractures, overall, n=2220, 222 | Non-high morbidity fractures, male, n=1142, 1152 | Non-high morbidity fractures, female, n=1078, 1075 | |
| Combined MET/SU: Main Study and Observational Follow-up | 46 | 15 | 31 | 1 | 0 | 1 | 4 | 3 | 1 |
| Combined RSG: Main Study and Observational Follow-up | 86 | 28 | 58 | 5 | 0 | 5 | 15 | 2 | 13 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown). (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any event, overall, n=2220, 2227 | Any event, male, n=1142, 1152 | Any event, female, n=1078, 1075 | Hip, overall, n=2220, 2227 | Hip, male, n=1142, 1152 | Hip, female, n=1078, 1075 | Pelvis, overall, n=2220, 2227 | Pelvis, male, n=1142, 1152 | Pelvis, female, n=1078, 1075 | Upper leg, overall, n=2220, 2227 | Upper leg, male, n=1142, 1152 | Upper leg, female, n=1078, 1075 | Any vertebral event, overall, n=2220, 2227 | Any vertebral event, male, n=1142, 1152 | Any vertebral event, female, n=1078, 1075 | Lumbar spine, overall, n=2220, 2227 | Lumbar spine, male, n=1142, 1152 | Lumbar spine, female, n=1078, 1075 | Thoracic spine, overall, n=2220, 2227 | Thoracic spine, male, n=1142, 1152 | Thoracic spine, female, n=1078, 1075 | Cervical spine, overall, n=2220, 2227 | Cervical spine, male, n=1142, 1152 | Cervical spine, female, n=1078, 1075 | |
| Combined MET/SU: Main Study and Observational Follow-up | 31 | 13 | 18 | 7 | 1 | 6 | 5 | 4 | 1 | 6 | 0 | 6 | 13 | 8 | 5 | 4 | 3 | 1 | 8 | 4 | 4 | 1 | 1 | 0 |
| Combined RSG: Main Study and Observational Follow-up | 31 | 10 | 21 | 9 | 0 | 9 | 0 | 0 | 0 | 7 | 4 | 3 | 16 | 6 | 10 | 10 | 5 | 5 | 5 | 1 | 4 | 1 | 0 | 1 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant. (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any event, overall; n=2220, 2227 | Any event, male; n=1142, 1152 | Any event, female; n=1078, 1075 | Upper limb, any event, overall; n=2220, 2227 | Upper limb, any event, male; n=1142, 1152 | Upper limb, any event, female; n=1078, 1075 | Distal lower limb, any event, overall; n=2220, 222 | Distal lower limb, any event, male; n=1142, 1152 | Distal lower limb, any event, female; n=1078, 1075 | Femur/hip, any event, overall; n=2220, 2227 | Femur/hip, any event, male; n=1142, 1152 | Femur/hip, any event, female; n=1078, 1075 | Spinal, any event, overall; n=2220, 2227 | Spinal, any event, male; n=1142, 1152 | Spinal, any event, female; n=1078, 1075 | Pelvic, any event, overall; n=2220, 2227 | Pelvic, any event, male; n=1142, 1152 | Pelvic, any event, female; n=1078, 1075 | Unclassified, any event, overall; n=2220, 2227 | Unclassified, any event, male; n=1142, 1152 | Unclassified, any event, female; n=1078, 1075 | Other, any event, overall; n=2220, 2227 | Other, any event, male; n=1142, 1152 | Other, any event, female; n=1078, 1075 | |
| Combined MET/SU: Main Study and Observational Follow-up | 151 | 60 | 91 | 70 | 22 | 48 | 40 | 14 | 26 | 13 | 1 | 12 | 14 | 9 | 5 | 5 | 4 | 1 | 0 | 0 | 0 | 26 | 16 | 10 |
| Combined RSG: Main Study and Observational Follow-up | 238 | 82 | 156 | 116 | 32 | 84 | 88 | 31 | 57 | 16 | 4 | 12 | 18 | 7 | 11 | 0 | 0 | 0 | 1 | 1 | 0 | 31 | 18 | 13 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant. (NCT00379769)
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
| Intervention | participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any event, overall; n=1280, 1250 | Any event, male; n=665, 635 | Any event, female; n=615, 615 | Upper limb, any event, overall; n=1280, 1250 | Upper limb, any event, male; n=665, 635 | Upper limb, any event, female; n=615, 615 | Distal lower limb, any event, overall; n=1280,1250 | Distal lower limb, any event, male; n=665, 635 | Distal lower limb, any event, female; n=615, 615 | Femur/hip, any event, overall; n=1280, 1250 | Femur/hip, any event, male; n=665, 635 | Femur/hip, any event, female; n=615, 615 | Spinal, any event, overall; n=1280, 1250 | Spinal, any event, male; n=665, 635 | Spinal, any event, female; n=615, 615 | Pelvic, any event, overall; n=1280, 1250 | Pelvic, any event, male; n=665, 635 | Pelvic, any event, female; n=615, 615 | Unclassified, any event, overall; n=1280, 1250 | Unclassified, any event, male; n=665, 635 | Unclassified, any event, female; n=615, 615 | Other, any event, overall; n=1280, 1250 | Other, any event, male; n=665, 635 | Other, any event, female; n=615, 615 | |
| Combined MET/SU: Observational Follow-up | 37 | 11 | 26 | 15 | 3 | 12 | 13 | 4 | 9 | 5 | 0 | 5 | 5 | 4 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Combined RSG: Observational Follow-up | 64 | 25 | 39 | 33 | 10 | 23 | 18 | 9 | 9 | 6 | 1 | 5 | 4 | 1 | 3 | 0 | 0 | 0 | 1 | 1 | 0 | 6 | 4 | 2 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE. (NCT00379769)
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any event | Ankle fracture | Prostate cancer | Lung neoplasm malignant | Breast cancer | Basal cell carcinoma | Pancreatic carcinoma | Colon cancer | Humerus fracture | Upper limb fracture | Malignant melanoma | Uterine cancer | Gastric cancer | Wrist fracture | Hip fracture | Radius fracture | Forearm fracture | Hepatic neoplasm malignant | Rectal cancer | Renal cancer | Foot fracture | Renal cell carcinoma | Femur fracture | Femoral neck fracture | Lumbar vertebral fracture | Metastases to bone | Metastases to liver | Bladder cancer | Fall | Metastases to central nervous system | Rib fracture | Squamous cell carcinoma | Acute myocardial infarction | Brain neoplasm | Gastric neoplasm | Metastases to lung | Patella fracture | Death | Abdominal pain | Acute myeloid leukaemia | Acute respiratory failure | Anaemia | Benign salivary gland neoplasm | Biliary colic | Biliary neoplasm | Bone neoplasm malignant | Bronchial carcinoma | Cardiac failure acute | Chest pain | Chronic lymphocytic leukaemia | Colon neoplasm | Contusion | Drowning | Dysplasia | Endometrial cancer stage I | Leukaemia | Lower limb fracture | Lung squamous cell carcinoma stage unspecified | Lymphoma | Malignant neoplasm of pleura | Metastases to skin | Metastases to testicle | Metastatic renal cell carcinoma | Oesophageal carcinoma | Osteoarthritis | Pancreatic necrosis | Rectal cancer stage II | Spinal fracture | T-cell lymphoma | Urinary tract infection | Uterine leiomyosarcoma | Biliary cancer metastatic | Cervix carcinoma | Chronic obstructive pulmonary disease | Comminuted fracture | Craniocerebral injury | Gastrointestinal neoplasm | Hepatic lesion | Joint dislocation | Laryngeal cancer | Lip neoplasm malignant stage unspecified | Lung neoplasm | Metastases to lymph nodes | Metastasis | Musculoskeletal chest pain | Myocardial infarction | Non-Hodgkin's lymphoma | Pubis fracture | Pulmonary embolism | Rectal cancer recurrent | Rectal neoplasm | Skin cancer | Skin ulcer | Small cell lung cancer stage unspecified | Sternal fracture | Subdural haemorrhage | Sudden death | Thoracic vertebral fracture | Thyroid cancer | Vulval cancer | |
| Combined MET/SU: Observational Follow-up | 76 | 3 | 1 | 4 | 6 | 3 | 3 | 6 | 1 | 1 | 2 | 3 | 0 | 0 | 1 | 1 | 2 | 2 | 2 | 2 | 3 | 0 | 1 | 2 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Combined RSG: Observational Follow-up | 99 | 6 | 7 | 4 | 2 | 4 | 4 | 1 | 5 | 5 | 3 | 2 | 4 | 4 | 3 | 3 | 2 | 2 | 2 | 2 | 1 | 3 | 2 | 1 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE. (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | participants (Number) | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any genitourinary | Prostate | Renal | Uterine | Bladder | Vaginal/vulvar | Ovarian | Any gastrointestinal | Colon/rectal cancer | Colon | Gastric | Pancreatic | Liver | Gall bladder/biliary | Gastrointestinal; not specified | Any hematologic | Lung | Skin (non-melanomatous) | Skin (melanomatous) | Metastases | Breast | Head and neck | Neurologic | Endocrine | Not specified | Other | |
| Combined MET/SU: Main Study and Observational Follow-up | 57 | 22 | 9 | 16 | 5 | 1 | 4 | 62 | 30 | 21 | 5 | 16 | 5 | 5 | 1 | 6 | 15 | 13 | 4 | 18 | 23 | 7 | 3 | 6 | 1 | 3 |
| Combined RSG: Main Study and Observational Follow-up | 57 | 22 | 12 | 11 | 8 | 1 | 5 | 48 | 22 | 14 | 13 | 5 | 4 | 4 | 0 | 12 | 19 | 19 | 6 | 12 | 12 | 4 | 3 | 3 | 0 | 0 |
The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE. (NCT00379769)
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
| Intervention | participants (Number) | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any genitourinary | Prostate | Renal | Uterine | Bladder | Vaginal/vulvar | Ovarian | Any gastrointestinal | Colon/rectal cancer | Colon | Gastric | Pancreatic | Liver | Gall bladder/biliary | Gastrointestinal; not specified | Any hematologic | Lung | Skin (non-melanomatous) | Skin (melanomatous) | Metastases | Breast | Head and neck | Neurologic | Endocrine | Not specified | Other | |
| Combined MET/SU: Observational Follow-up | 8 | 1 | 2 | 4 | 0 | 1 | 0 | 19 | 11 | 7 | 1 | 3 | 2 | 1 | 1 | 1 | 6 | 5 | 2 | 6 | 7 | 1 | 1 | 1 | 0 | 0 |
| Combined RSG: Observational Follow-up | 18 | 7 | 5 | 4 | 2 | 0 | 0 | 17 | 5 | 2 | 5 | 4 | 2 | 1 | 0 | 6 | 6 | 6 | 3 | 3 | 2 | 2 | 1 | 0 | 0 | 0 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE. (NCT00379769)
Timeframe: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
| Intervention | participants (Number) | ||
|---|---|---|---|
| All neoplasms/cancer (N/C) (benign/malignant) | Malignant (Mal.) N/C | Mal. N/C; excluding non-melanomatous skin cancers | |
| Combined MET/SU: Main Study and Observational Follow-up | 215 | 195 | 186 |
| Combined RSG: Main Study and Observational Follow-up | 196 | 179 | 164 |
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE. (NCT00379769)
Timeframe: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
| Intervention | participants (Number) | ||
|---|---|---|---|
| All neoplasms/cancer (N/C) (benign/malignant) | Malignant (Mal.) N/C | Mal. N/C; excluding non-melanomatous skin cancers | |
| Combined MET/SU: Observational Follow-up | 51 | 51 | 46 |
| Combined RSG: Observational Follow-up | 60 | 59 | 55 |
The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction. (NCT00379769)
Timeframe: Baseline through End of Study (up to 7.5 years)
| Intervention | Number of events (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CV deaths | Death due to acute MI | Death due to heart failure | Sudden death | Death due to acute vascular events | Other CV mortality | Death of presumed CV cause | Cardiovascular hospitalisation | Hospitalisation for acute MI | Hospitalisation for unstable angina | Hospitalisation for congestive heart failure | Hospitalisation for stroke | Hospitalisation for transient ischaemic attack | Hospitalisation for invasive CV procedure | Hospitalisation for amputation of extremities | Other CV hospitalisations | |
| Combined MET/SU | 71 | 10 | 2 | 12 | 10 | 4 | 33 | 490 | 57 | 28 | 36 | 67 | 10 | 116 | 23 | 153 |
| Combined RSG | 60 | 7 | 10 | 8 | 1 | 6 | 28 | 483 | 66 | 28 | 69 | 51 | 10 | 99 | 6 | 154 |
High sensitivity C-reactive protein (range 0 - no maximum) (NCT01991197)
Timeframe: 16 weeks
| Intervention | µg/ml (Median) |
|---|---|
| Sitagliptin | 0 |
| Gliclazide | 8.4 |
The change in glucose from baseline to 16 weeks (NCT01991197)
Timeframe: 16 weeks
| Intervention | mmol/L (Median) |
|---|---|
| Sitagliptin | -0.2 |
| Gliclazide | -0.1 |
The change in systolic blood pressure from baseline to 16 weeks measured in kg (NCT01991197)
Timeframe: 16 weeks
| Intervention | mmHg (Median) |
|---|---|
| Sitagliptin | 4 |
| Gliclazide | -9 |
The change in total cholesterol from baseline to 16 weeks (NCT01991197)
Timeframe: 16 weeks
| Intervention | mmol/L (Median) |
|---|---|
| Sitagliptin | 0.1 |
| Gliclazide | -0.1 |
Psoriasis area and severity index 0-72, higher score worse outcome (NCT01991197)
Timeframe: baseline and 32 weeks
| Intervention | score on a scale (Median) |
|---|---|
| Sitagliptin | 3 |
| Gliclazide | 1.8 |
Psoriasis area and severity index (0-72), higher scores worse outcome (NCT01991197)
Timeframe: 16 weeks
| Intervention | score on a scale (Median) |
|---|---|
| Sitagliptin | 9.5 |
| Gliclazide | 9.4 |
The change in weight from baseline to 16 weeks measured in kg (NCT01991197)
Timeframe: 16 weeks
| Intervention | kg (Median) |
|---|---|
| Sitagliptin | -0.5 |
| Gliclazide | -0.6 |
Dipeptidyl peptidase-4 levels levels in skin (0-no maximum) (NCT01991197)
Timeframe: 16 weeks
| Intervention | dCt (Median) |
|---|---|
| Gliclazide | -1.12 |
| Sitagliptin | 0 |
Interleukin 17 levels in skin (0-no maximum) (NCT01991197)
Timeframe: 16 weeks
| Intervention | dCt (Median) |
|---|---|
| Sitagliptin | 3.41 |
| Gliclazide | 2.09 |
"Secondary outcomes:~The change in serum concentrations of the cytokine interleukin-17 (IL-17) Range: 0-no maximum" (NCT01991197)
Timeframe: 16 weeks
| Intervention | pg/ml (Median) |
|---|---|
| Sitagliptin | 0 |
| Gliclazide | 0 |
"Secondary outcomes:~The change in serum concentrations of the cytokine interleukin-23 (IL-23) Range: 0-no maximum" (NCT01991197)
Timeframe: 16 weeks
| Intervention | pg/ml (Median) |
|---|---|
| Sitagliptin | 0 |
| Gliclazide | 0 |
"Secondary outcomes:~The change in serum concentrations of the adipokine leptin Range: 0-no maximum" (NCT01991197)
Timeframe: 16 weeks
| Intervention | pg/ml (Median) |
|---|---|
| Sitagliptin | -0.07 |
| Gliclazide | 0.43 |
"Secondary outcomes:~The change in serum concentrations of the cytokines tumour necrosis factor alpha (TNFα) Range: 0-no maximum" (NCT01991197)
Timeframe: 16 weeks
| Intervention | pg/ml (Median) |
|---|---|
| Sitagliptin | 0 |
| Gliclazide | 0 |
"Dosage: Sitagliptin: 100mg daily, or 50mg daily for participants with moderate kidney disease Gliclazide: 80-320 mg daily.~Secondary outcomes: the number participants with adverse events." (NCT01991197)
Timeframe: 32 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Sitagliptin | 6 |
| Gliclazide | 10 |
"Dermatology life quality index (a skin related quality of life measure) (0-10), higher score worse outcome EQ-5D Euroqol 5 item quality of life index comprising 5 dimensions mobility, self-care, usual activities, pain, anxiety. An index can be derived from these 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state and minimum score indicating the worst health outcome -0.594.~HADS Hospital anxiety and depression scale 0-16 for anxiety and 0-16 for depression, higher score worse outcome HAQ-8 Stanford 8 item disability scale. Scoring is from 0 (without any difficulty) to 3 (unable to do). The 8 scores from the 8 sections are summed and divided by 8. The result is the disability index (range 0-3 with 25 possible values). A" (NCT01991197)
Timeframe: 16 weeks
| Intervention | score on a scale (Median) | ||||
|---|---|---|---|---|---|
| DLQI | HAQ-8 | HADS Anxiety | HADS Depression | EQ-5D | |
| Gliclazide | -1.0 | 0.0 | 0 | 0 | -0.2 |
| Sitagliptin | 0.0 | 0.0 | -1 | 0 | 0 |
"Secondary outcomes:~d. number or participants who acheived a greater than 50% reduction in PASI from baseline (PASI-50); e. number of participants who achieved PASI-75 and PASI-90." (NCT01991197)
Timeframe: 16 weeks
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| PASI 50 | PASI 75 | PASI 90 | |
| Gliclazide | 1 | 0 | 0 |
| Sitagliptin | 1 | 0 | 0 |
Grip strength over time. (NCT03772964)
Timeframe: Day 0 (baseline), 90, and 120 (30 days post metformin exposure)
| Intervention | mmHg (Mean) | ||
|---|---|---|---|
| 0 days | 90 days, compared to 0 days | 120 days, compared to 0 days | |
| 1000mg Exposure | 28.9 | -0.4 | 1.1 |
| 1500mg Exposure | 25.7 | -.2 | .3 |
| 500mg Exposure | 28.2 | -5.3 | .1 |
| Placebo | 25.7 | -.3 | -.6 |
The SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. The minimum is zero (worse performance) and the maximum is 12 (best performance). (NCT03772964)
Timeframe: Day 0 (baseline), 90, and 120 (30 days post metformin exposure)
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| 0d | 90d, change from 0d | 120d, change from 0d | |
| 1000mg Exposure | 10.8 | 0.4 | 0.2 |
| 1500mg Exposure | 11.1 | 0.4 | 0.3 |
| 500mg Exposure | 11.2 | -0.3 | 0 |
| Placebo | 10.6 | 1.0 | 0.5 |
Aggregometry area under the curve with the Y-axis being % aggregometry and the X-axis time in minutes. (NCT03772964)
Timeframe: Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)
| Intervention | arbitrary units*mins (Mean) | ||||
|---|---|---|---|---|---|
| 0 days | 30 day change from day 0 | 60 days change from day 0 | 90 days change from day 0 | 120 days change from day 0 | |
| 1000mg Exposure | 67 | 8.9 | -23.5 | 2.4 | 1.0 |
| 1500mg Exposure | 196 | -166.7 | -139.8 | -222.5 | -196.7 |
| 500mg Exposure | 56.3 | -34.7 | -28.3 | 1.6 | -49.2 |
| Placebo | 83.3 | -29.6 | -49.4 | -66.6 | -47.6 |
"Bacterial communities using 16S rRNA sequencing in relationship to metformin dosing over time. Species richness or diversity in the sample is measured by Choa1 metric. Chao1 is an estimate of how many species are present in an ecosystem. In general, having more species is considered to be healthier and these values typically range from 100-200 for fecal samples. The Chao1 index over numerous samples across time are explored to understand treatment effects." (NCT03772964)
Timeframe: Day 0 (baseline), 30, 60, 90, and 120 (30 days post metformin exposure)
| Intervention | Index (Mean) | ||||
|---|---|---|---|---|---|
| Day 0 | Day 30 | Day 60 | Day 90 | Day 120 | |
| 1000mg Exposure | 107.6 | 130.7 | 137.9 | 135 | 142.2 |
| 1500mg Exposure | 128.1 | 128.1 | 128.6 | 138.2 | 144.2 |
| 500mg Exposure | 136.5 | 139.9 | 121.4 | 137.8 | 134 |
| Placebo | 141.5 | 144.75 | 134.3 | 152 | 159.2 |
24 hour blood pressure measurements were performed after each treatment/diet phase (NCT01090752)
Timeframe: march 2009
| Intervention | mmHg (Mean) |
|---|---|
| Pioglitazone Low Salt/High Salt | 128 |
| Placebo Low Salt/High Salt | 129 |
At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF (NCT01090752)
Timeframe: 2008
| Intervention | ml/min/1.73m2 (Mean) |
|---|---|
| Pioglitazone Low Salt/High Salt | 68.0 |
| Placebo Low Salt/High Salt | 62.4 |
At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances (NCT01090752)
Timeframe: 2007
| Intervention | ml/min (Mean) |
|---|---|
| Pioglitazone Low Salt/High Salt | 1.05 |
| Placebo Low Salt/High Salt | 1.18 |
fasting blood glucose (NCT00816907)
Timeframe: 16 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | -1.6 |
| Metformin | -2.3 |
Fasting insulin (NCT00816907)
Timeframe: 16 weeks
| Intervention | mU/L (Mean) |
|---|---|
| Placebo | 5.5 |
| Metformin | 1.6 |
high-density lipoprotein (NCT00816907)
Timeframe: 16 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | -0.4 |
| Metformin | -0.6 |
glycosylated hemoglobin (NCT00816907)
Timeframe: 16 weeks
| Intervention | percent (Least Squares Mean) |
|---|---|
| Placebo | 0.01 |
| Metformin | -0.06 |
low-density lipoprotein (NCT00816907)
Timeframe: 16 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | -2.0 |
| Metformin | -7.1 |
Total cholesterol (NCT00816907)
Timeframe: 16 weeks
| Intervention | mg/dL (Mean) |
|---|---|
| Placebo | 0.2 |
| Metformin | -8.9 |
serum triglycerides (NCT00816907)
Timeframe: 16 weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Placebo | 13.2 |
| Metformin | -7.0 |
Mean difference in body weight change between participants assigned to metformin and participants assigned to placebo from baseline to last study visit (up to 16 weeks) (NCT00816907)
Timeframe: Measured at the last study visit
| Intervention | kilograms (Mean) |
|---|---|
| Placebo | -1.0 |
| Metformin | -3.0 |
Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | kg (Least Squares Mean) |
|---|---|
| Exenatide Arm | -1.78 |
| Placebo Arm | 0.96 |
Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | insulin units (U) (Least Squares Mean) |
|---|---|
| Exenatide Arm | 13.19 |
| Placebo Arm | 19.71 |
Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | insulin units per kg (U/kg) (Least Squares Mean) |
|---|---|
| Exenatide Arm | 0.15 |
| Placebo Arm | 0.20 |
Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Exenatide Arm | -1.73 |
| Placebo Arm | 1.69 |
Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide Arm | -1.28 |
| Placebo Arm | -0.87 |
Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated. (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | percentage of hemoglobin (Least Squares Mean) |
|---|---|
| Exenatide Arm | -1.71 |
| Placebo Arm | -1.00 |
Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide Arm | 0.01 |
| Placebo Arm | 0.00 |
Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide Arm | -0.19 |
| Placebo Arm | -0.00 |
Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Exenatide Arm | -2.74 |
| Placebo Arm | 1.71 |
Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide Arm | -0.16 |
| Placebo Arm | -0.02 |
Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide Arm | -0.02 |
| Placebo Arm | -0.03 |
Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | cm (Least Squares Mean) |
|---|---|
| Exenatide Arm | -1.08 |
| Placebo Arm | -0.25 |
Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL). (NCT00765817)
Timeframe: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
| Intervention | events per subject per year (Mean) |
|---|---|
| Exenatide Arm | 1.61 |
| Placebo Arm | 1.55 |
Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%). (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | percentage (Number) |
|---|---|
| Exenatide Arm | 42.0 |
| Placebo Arm | 13.3 |
Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%). (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | percentage (Number) |
|---|---|
| Exenatide Arm | 58.3 |
| Placebo Arm | 31.1 |
Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL). (NCT00765817)
Timeframe: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
| Intervention | percentage (Number) |
|---|---|
| Exenatide Arm | 24.8 |
| Placebo Arm | 28.7 |
Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline) (NCT00765817)
Timeframe: baseline and 30 weeks
| Intervention | mmol/L (Least Squares Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-breakfast: baseline | Pre-breakfast: change at week 30 | 2 hour post-breakfast: baseline | 2 hour post-breakfast: change at week 30 | Pre-lunch: baseline | Pre-lunch: change at week 30 | 2 hour post-lunch: baseline | 2 hour post-lunch: change at week 30 | Pre-dinner: baseline | Pre-dinner: change at week 30 | 2 hour post-dinner: baseline | 2 hour post-dinner: change at week 30 | 0300: baseline | 0300: change at week 30 | |
| Exenatide Arm | 7.89 | -1.58 | 10.89 | -3.56 | 8.95 | -2.23 | 11.35 | -2.74 | 9.85 | -2.25 | 12.03 | -3.87 | 8.95 | -2.27 |
| Placebo Arm | 8.27 | -1.48 | 11.82 | -1.72 | 9.77 | -1.15 | 11.70 | -1.38 | 9.99 | -1.33 | 11.86 | -1.34 | 9.20 | -1.48 |
Change in body fat mass measured by air displacement plethysmography (kg) (NCT00005669)
Timeframe: 6 months
| Intervention | kg (Mean) |
|---|---|
| Metformin Plus Weight Reduction Counseling | -1.51 |
| Placebo Plus Weight Reduction Counseling | 1.81 |
Change in body fat mass by Dual Energy X-Ray Absorptiometry (kg) (NCT00005669)
Timeframe: 6 months
| Intervention | kg (Mean) |
|---|---|
| Metformin Plus Weight Reduction Counseling | 0.48 |
| Placebo Plus Weight Reduction Counseling | 1.88 |
Change in body weight (kg) (NCT00005669)
Timeframe: 6 months
| Intervention | kg (Mean) |
|---|---|
| Metformin Plus Weight Reduction Counseling | 1.47 |
| Placebo Plus Weight Reduction Counseling | 4.85 |
Change in body weight as determined by body mass index (kg/m2) (NCT00005669)
Timeframe: 6 months
| Intervention | kg/m2 (Mean) |
|---|---|
| Metformin Plus Weight Reduction Counseling | -0.78 |
| Placebo Plus Weight Reduction Counseling | 0.32 |
Change in Body Mass Index standard deviation score (BMI-SDS) determined using tables created by the CDC in 2000. BMI-SDS is a unitless transformation of the body mass index (measured in kg divided by the squared height in meters) using the L M S method. Possible values range from -3 to +3. See http://www.cdc.gov/growthcharts/percentile_data_files.htm for details. (NCT00005669)
Timeframe: 6 months
| Intervention | Units on a scale (Mean) |
|---|---|
| Metformin Plus Weight Reduction Counseling | -0.11 |
| Placebo Plus Weight Reduction Counseling | -0.07 |
Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline [week -2]). (NCT00097500)
Timeframe: Baseline (week -2) and 56 weeks
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Exenatide Arm | 1.02 |
| Insulin Glargine Arm | 1.08 |
Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline [week -2]). (NCT00097500)
Timeframe: Baseline (week -2) and 52 weeks
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Exenatide Arm | 2.89 |
| Insulin Glargine Arm | 1.15 |
Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0). (NCT00097500)
Timeframe: 0 weeks and 52 weeks
| Intervention | kg (Least Squares Mean) |
|---|---|
| Exenatide Arm | -3.80 |
| Insulin Glargine Arm | 0.75 |
Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0). (NCT00097500)
Timeframe: 0 weeks and 52 weeks
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Exenatide Arm | -1.53 |
| Insulin Glargine Arm | -3.10 |
Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0). (NCT00097500)
Timeframe: Week 0 and week 52
| Intervention | percent (Least Squares Mean) |
|---|---|
| Exenatide Arm | -0.97 |
| Insulin Glargine Arm | -0.87 |
Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure. (NCT00097500)
Timeframe: baseline (week -2), 52 weeks, and 56 weeks
| Intervention | ratio (Least Squares Mean) | |
|---|---|---|
| 52 weeks | 56 weeks | |
| Exenatide Arm | 1.72 | 0.95 |
| Insulin Glargine Arm | 1.13 | 1.06 |
Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure. (NCT00097500)
Timeframe: baseline (-2 weeks), 52 weeks, and 56 weeks
| Intervention | ratio (Least Squares Mean) | |
|---|---|---|
| 52 weeks | 56 weeks | |
| Exenatide Arm | 2.88 | 1.00 |
| Insulin Glargine Arm | 1.01 | 1.08 |
M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp. (NCT00097500)
Timeframe: baseline (week -2), 52 weeks, and 56 weeks
| Intervention | mg/min/kg (Mean) | ||
|---|---|---|---|
| baseline (week -2) | week 52 | week 56 | |
| Exenatide Arm | 2.24 | 3.18 | 3.19 |
| Insulin Glargine Arm | 2.79 | 3.85 | 2.81 |
SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime). (NCT00097500)
Timeframe: 0 weeks and 52 weeks
| Intervention | mmol/L (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-breakfast measurement (week 0) | Pre-breakfast measurement (week 52) | 2-hour post-breakfast measurement (week 0) | 2-hour post-breakfast measurement (week 52) | Pre-lunch measurement (week 0) | Pre-lunch measurement (week 52) | 2-hour post-lunch measurement (week 0) | 2-hour post-lunch measurement (week 52) | Pre-dinner measurement (week 0) | Pre-dinner measurement (week 52) | 2-hour post-dinner measurement (week 0) | 2-hour post-dinner measurement (week 52) | Bedtime measurement (week 0) | Bedtime measurement (week 52) | |
| Exenatide Arm | 8.92 | 7.27 | 11.00 | 6.98 | 8.14 | 6.52 | 9.90 | 7.97 | 8.38 | 7.53 | 10.42 | 6.98 | 9.76 | 7.61 |
| Insulin Glargine Arm | 8.38 | 5.63 | 11.17 | 7.53 | 8.54 | 6.24 | 10.52 | 8.15 | 8.07 | 6.98 | 10.26 | 8.81 | 9.85 | 8.03 |
The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes. (NCT01432405)
Timeframe: one year
| Intervention | percent of liver fat (Mean) |
|---|---|
| Pioglitazone and Exenatide | 4.7 |
| Pioglitazone | 6.5 |
the effect of the intervention on plasma adiponectin levels. (NCT01432405)
Timeframe: one year
| Intervention | microgram per ml (Mean) |
|---|---|
| Pioglitazone and Exenatide | 23.2 |
| Pioglitazone | 15.8 |
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the double-blind period. (NCT00643851)
Timeframe: From Baseline to Week 24
| Intervention | mg/dL (Mean) |
|---|---|
| Dapagliflozin 5 mg + Metformin XR | -61.0 |
| Dapagliflozin 5 mg | -42.0 |
| Metformin XR | -33.6 |
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double- blind period. (NCT00643851)
Timeframe: From Baseline to Week 24
| Intervention | % of hemoglobin (Mean) |
|---|---|
| Dapagliflozin 5 mg + Metformin XR | -2.05 |
| Dapagliflozin 5 mg | -1.19 |
| Metformin XR | -1.35 |
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period. (NCT00643851)
Timeframe: From Baseline to Week 24
| Intervention | % of hemoglobin (Mean) |
|---|---|
| Dapagliflozin 5 mg + Metformin XR | -3.01 |
| Dapagliflozin 5 mg | -1.67 |
| Metformin XR | -1.82 |
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00643851)
Timeframe: From Baseline to Week 24
| Intervention | kg (Mean) |
|---|---|
| Dapagliflozin 5 mg + Metformin XR | -2.66 |
| Dapagliflozin 5 mg | -2.61 |
| Metformin XR | -1.29 |
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00643851)
Timeframe: From Baseline to Week 24
| Intervention | kg (Mean) |
|---|---|
| Dapagliflozin 5 mg + Metformin XR | -3.04 |
| Dapagliflozin 5 mg | -2.88 |
| Metformin XR | -1.47 |
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants estimated by modified logistic regression model. (NCT00643851)
Timeframe: From Baseline to Week 24
| Intervention | Percentage of participants (Mean) |
|---|---|
| Dapagliflozin 5 mg + Metformin XR | 52.4 |
| Dapagliflozin 5 mg | 22.5 |
| Metformin XR | 34.6 |
(NCT00751114)
Timeframe: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value
| Intervention | kg (Least Squares Mean) |
|---|---|
| Insulin Glargine | 0.44 |
| Sitagliptin | -1.08 |
(NCT00751114)
Timeframe: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Glargine | 40.2 |
| Sitagliptin | 16.9 |
(NCT00751114)
Timeframe: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
| Intervention | percentage of participants (Number) |
|---|---|
| Insulin Glargine | 67.9 |
| Sitagliptin | 41.9 |
Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period. (NCT00751114)
Timeframe: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
| Intervention | percent (Least Squares Mean) |
|---|---|
| Insulin Glargine | -1.72 |
| Sitagliptin | -1.13 |
Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level < 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration (NCT00751114)
Timeframe: During the treatment phase (24 weeks) plus 7 days after last dose
| Intervention | participants (Number) |
|---|---|
| Insulin Glargine | 3 |
| Sitagliptin | 1 |
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L] (NCT00751114)
Timeframe: During the treatment phase (24 weeks) plus 7 days after last dose
| Intervention | participants (Number) |
|---|---|
| Insulin Glargine | 108 |
| Sitagliptin | 35 |
"SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).~Study endpoint was defined as the last available SMFPG mean value collected on-treatment.~Change= study endpoint - baseline" (NCT00751114)
Timeframe: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Insulin Glargine | -60.52 |
| Sitagliptin | -19.35 |
"7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.~Change = study endpoint - baseline." (NCT00751114)
Timeframe: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
| Intervention | mg/dL (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Before breakfast (N ig = 203 & N s = 226) | After breakfast (N ig = 202 & N s = 220) | Before lunch (N ig = 201 & N s = 223) | After lunch (N ig = 202 & N s = 226) | Before dinner (N ig = 199 & N s = 223) | After dinner (N ig = 196 & N s = 220) | At bedtime (N ig = 177 & N s = 210) | |
| Insulin Glargine | -59.90 | -66.25 | -48.00 | -45.54 | -40.68 | -45.88 | -45.58 |
| Sitagliptin | -20.39 | -36.41 | -19.82 | -26.10 | -25.07 | -33.78 | -31.16 |
Daily dose at the face-to-face visits. (NCT00751114)
Timeframe: visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value
| Intervention | unit per kg body weight (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| First dose received N=236 | Visit 4 (week 2) N=230 | Visit 8 (week 6) N=222 | Visit 11 (week 12) N=219 | Visit 12 (week 16) N=214 | Visit 14 (week 24) N=220 | Study endpoint N=237 | |
| Insulin Glargine | 0.19 | 0.27 | 0.38 | 0.45 | 0.48 | 0.50 | 0.49 |
(NCT00751114)
Timeframe: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
| Intervention | mg/dL (Least Squares Mean) | |||
|---|---|---|---|---|
| Change in Total Cholesterol | Change in LDL Cholesterol | Change in HDL Cholesterol | Change in Triglycerides | |
| Insulin Glargine | -7.94 | -3.68 | 0.13 | -34.07 |
| Sitagliptin | -1.54 | -0.19 | 0.57 | 0.31 |
Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mcg/mL (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 1.69 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 1.51 |
| Sita -> Sita | 1.35 |
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | g/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.06 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.07 |
| Sita -> Sita | -0.05 |
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | g/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.03 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.03 |
| Sita -> Sita | -0.03 |
"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)." (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | percentage point (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 27.23 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 28.70 |
| Sita -> Sita | 4.18 |
"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)." (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | percentage point (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 22.58 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 25.76 |
| Sita -> Sita | 3.98 |
Calculated as an estimate of the mean change from baseline in body weight at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | kg (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -2.86 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -3.38 |
| Sita -> Sita | -0.96 |
Calculated as an estimate of the mean change from baseline in body weight at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | kg (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -2.78 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -3.68 |
| Sita -> Sita | -1.16 |
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.71 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0.07 |
| Sita -> Sita | -1.78 |
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.53 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.87 |
| Sita -> Sita | -1.47 |
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -1.87 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -2.14 |
| Sita -> Sita | -0.83 |
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -1.71 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -2.04 |
| Sita -> Sita | -0.59 |
Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78. (NCT00700817)
Timeframe: Week 0, Week 78
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -1.30 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -1.65 |
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.03 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.07 |
| Sita -> Sita | -0.05 |
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.07 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.10 |
| Sita -> Sita | -0.06 |
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | Percentage point of total HbA1c (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -1.24 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -1.5 |
| Sita -> Sita | -0.9 |
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | Percentage point of total HbA1c (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -1.29 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -1.51 |
| Sita -> Sita | -0.88 |
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78. (NCT00700817)
Timeframe: Week 0, Week 78
| Intervention | Percentage point of total HbA1c (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.94 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -1.28 |
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 0.00 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0.00 |
| Sita -> Sita | 0.00 |
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 0.01 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0.02 |
| Sita -> Sita | 0.01 |
Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mg/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -1.02 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.99 |
| Sita -> Sita | -0.66 |
Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | pg/mL (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -1.70 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 1.71 |
| Sita -> Sita | 0.91 |
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 0.08 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0.05 |
| Sita -> Sita | 0.13 |
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 0.09 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0.09 |
| Sita -> Sita | 0.17 |
Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | pmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 5.19 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 3.74 |
| Sita -> Sita | 3.71 |
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 3.51 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 4.35 |
| Sita -> Sita | 2.96 |
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 3.32 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 4.31 |
| Sita -> Sita | 2.96 |
Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | U/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -833 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -561 |
| Sita -> Sita | 586 |
Calculated as an estimate of the mean change from baseline in pulse at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | beats/minute (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 2.32 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 3.94 |
| Sita -> Sita | -0.64 |
Calculated as an estimate of the mean change from baseline in pulse at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 1.72 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 3.09 |
| Sita -> Sita | 0.09 |
Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.55 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.72 |
| Sita -> Sita | -0.94 |
Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.37 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -2.55 |
| Sita -> Sita | -1.03 |
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.03 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.17 |
| Sita -> Sita | -0.02 |
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.01 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.09 |
| Sita -> Sita | 0.03 |
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.19 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.43 |
| Sita -> Sita | -0.40 |
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.10 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.32 |
| Sita -> Sita | -0.23 |
Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | pg/mL (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.55 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.74 |
| Sita -> Sita | -0.53 |
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.11 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.20 |
| Sita -> Sita | -0.15 |
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | mmol/L (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.11 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.19 |
| Sita -> Sita | -0.15 |
Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | percentage point (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -1.73 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -4.34 |
| Sita -> Sita | -1.8 |
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | cm (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -2.69 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -2.63 |
| Sita -> Sita | -1.12 |
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | participants (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -2.36 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -3.02 |
| Sita -> Sita | -1.23 |
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip. (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | cm/cm (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.01 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.01 |
| Sita -> Sita | -0.00 |
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip. (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | cm/cm (Least Squares Mean) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | -0.00 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | -0.01 |
| Sita -> Sita | -0.00 |
Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | mmol/L (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | 0.23 |
| Sita -> Sita -> Lira 1.8 mg | 0.17 |
Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | percentage point (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | 13.31 |
| Sita -> Sita -> Lira 1.8 mg | 23.09 |
Mean change in body weight from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | kg (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | -1.64 |
| Sita -> Sita -> Lira 1.8 mg | -2.48 |
Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | mmHg (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | -0.60 |
| Sita -> Sita -> Lira 1.8 mg | 0.03 |
Mean change in fasting plasma glucose (FPG) Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | mmol/L (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | -0.84 |
| Sita -> Sita -> Lira 1.8 mg | -1.42 |
Mean change in free fatty acids (FFA) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | mmol/L (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | 0.02 |
| Sita -> Sita -> Lira 1.8 mg | -0.01 |
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78 (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | Percentage point of total HbA1c (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | -0.24 |
| Sita -> Sita -> Lira 1.8 mg | -0.45 |
Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | mmol/L (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | 0.02 |
| Sita -> Sita -> Lira 1.8 mg | -0.01 |
Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | mmol/L (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | -0.22 |
| Sita -> Sita -> Lira 1.8 mg | -0.25 |
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | scores on a scale (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | 1.48 |
| Sita -> Sita -> Lira 1.8 mg | 0.98 |
Mean change in pulse from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | beats/minute (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | 0.90 |
| Sita -> Sita -> Lira 1.8 mg | 2.19 |
Mean change in systolic blood pressure (SBP) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | mmHg (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | -2.12 |
| Sita -> Sita -> Lira 1.8 mg | 0.35 |
Mean change in total cholesterol from Week 52 to Week 78 (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | mmol/L (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | -0.16 |
| Sita -> Sita -> Lira 1.8 mg | -0.24 |
Mean change in triglycerides (TG) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | mmol/L (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | -0.20 |
| Sita -> Sita -> Lira 1.8 mg | -0.26 |
Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | mmol/L (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | 0.03 |
| Sita -> Sita -> Lira 1.8 mg | 0.02 |
Mean change in Waist Circumference from Week 52 to Week 78. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | kg (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | -1.33 |
| Sita -> Sita -> Lira 1.8 mg | -2.05 |
Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip. (NCT00700817)
Timeframe: Week 52, Week 78
| Intervention | cm/cm (Mean) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | -0.01 |
| Sita -> Sita -> Lira 1.8 mg | -0.00 |
Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | percentage of subjects (Number) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 43 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 55 |
| Sita -> Sita | 22 |
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52 (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | percentage of subjects (Number) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 50 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 63 |
| Sita -> Sita | 27 |
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS. (NCT00700817)
Timeframe: Week 0, Week 78
| Intervention | percentage of subjects (Number) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | 49 |
| Sita -> Sita -> Lira 1.8 mg | 50 |
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS. (NCT00700817)
Timeframe: Week 0, Week 78
| Intervention | percentage of subjects (Number) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 35 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 51 |
Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26 (NCT00700817)
Timeframe: Week 0, Week 26
| Intervention | percentage of subjects (Number) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 23 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 36 |
| Sita -> Sita | 12 |
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52 (NCT00700817)
Timeframe: Week 0, Week 52
| Intervention | percentage of subjects (Number) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 24 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 40 |
| Sita -> Sita | 17 |
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS. (NCT00700817)
Timeframe: Week 0, Week 78
| Intervention | percentage of subjects (Number) |
|---|---|
| Sita -> Sita -> Lira 1.2 mg | 29 |
| Sita -> Sita -> Lira 1.8 mg | 25 |
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS. (NCT00700817)
Timeframe: Week 0, Week 78
| Intervention | percentage of subjects (Number) |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 12 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 27 |
Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Week 52-78
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| Major | Minor | Symptoms only | Unclassified | |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 1 | 12 | 3 | 0 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0 | 5 | 11 | 0 |
| Sita -> Sita -> Lira 1.2 mg | 0 | 3 | 1 | 0 |
| Sita -> Sita -> Lira 1.8 mg | 0 | 6 | 0 | 0 |
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| Major | Minor | Symptoms only | Unclassified | |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 1 | 17 | 12 | 0 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0 | 16 | 15 | 1 |
| Sita -> Sita | 0 | 11 | 10 | 0 |
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-52
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| Major | Minor | Symptoms only | Unclassified | |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 1 | 24 | 14 | 0 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0 | 28 | 29 | 1 |
| Sita -> Sita | 0 | 25 | 12 | 0 |
Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-78
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| Major | Minor | Symptoms only | Unclassified | |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 2 | 36 | 18 | 0 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0 | 33 | 40 | 1 |
| Sita -> Sita | 0 | 34 | 13 | 0 |
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-26
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| Major | Minor | Symptoms only | Unclassified | |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 1 | 17 | 12 | 0 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0 | 37 | 15 | 1 |
| Sita -> Sita | 0 | 11 | 10 | 0 |
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-52
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| Major | Minor | Symptoms only | Unclassified | |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 1 | 24 | 14 | 0 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0 | 51 | 29 | 1 |
| Sita -> Sita | 0 | 25 | 12 | 0 |
Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. (NCT00700817)
Timeframe: Weeks 0-78
| Intervention | episodes (Number) | |||
|---|---|---|---|---|
| Major | Minor | Symptoms only | Unclassified | |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | 2 | 36 | 18 | 0 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | 0 | 56 | 40 | 1 |
| Sita -> Sita | 0 | 34 | 13 | 0 |
Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin. (NCT01589445)
Timeframe: 3 months for each drug
| Intervention | mmol/l (Mean) | |
|---|---|---|
| Baseline FSG | 3rd Month FSG | |
| Metformin ( 002 Group) | 6.2 | 6.5 |
| Pioglitazone (001 Group) | 6.9 | 5.4 |
Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin. (NCT01589445)
Timeframe: 3 months for each drug
| Intervention | μU/ml (Mean) | |
|---|---|---|
| Baseline FSI | 3rd month FSI | |
| Metformin ( 002 Group) | 13.0 | 13.9 |
| Pioglitazone (001 Group) | 16.2 | 12.3 |
Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin. (NCT01589445)
Timeframe: 3 months for each drug
| Intervention | percentage (Mean) | |
|---|---|---|
| Baseline HbA1c | 3rd month HbA1c | |
| Metformin ( 002 Group) | 7.8 | 7.0 |
| Pioglitazone (001 Group) | 7.3 | 6.7 |
"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1: Homeostatic Model Assessment of Beta cell function(HOMA percent B) Analysis 2: Homeostatic Model Assessment of Insulin Sensitivity (Homa percent S)" (NCT01589445)
Timeframe: 3 months for each drug
| Intervention | percentage (Mean) | |||
|---|---|---|---|---|
| Baseline HOMA percent beta cells function | 3rd month HOMA percent beta cells function | Baseline HOMA percent sensitivity | 3rd month HOMA percent sensitivity | |
| Metformin ( 002 Group) | 109.3 | 116.0 | 76.2 | 67.2 |
| Pioglitazone (001 Group) | 118.9 | 132.3 | 51.1 | 69.3 |
"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1: Homeostasis Model Assessment Insulin Resistance(HOMA IR) Analysis 2: Quantitative Insulin sensitivity Check Index(QUICKI)" (NCT01589445)
Timeframe: 3 months for each drug
| Intervention | Score on a scale ( SI unit) (Mean) | |||
|---|---|---|---|---|
| Baseline QUICKI | 3rd month QUICKI | Baseline HOMA IR | 3rd month HOMA IR | |
| Metformin ( 002 Group) | 0.57 | 0.54 | 3.7 | 4.3 |
| Pioglitazone (001 Group) | 0.52 | 0.59 | 5.1 | 2.9 |
"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1:Total Cholesterol(TC) Analysis 2:Triglyceride(TG) Analysis 3:High Density Lipoprotein(HDL) Analysis 4:Low Density Lipoprotein(LDL)" (NCT01589445)
Timeframe: 3 months for each drug
| Intervention | mg/dl (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Baseline TC | 3rd month TC | Baseline TG | 3rd month TG | Baseline HDL | 3rd month HDL | Baseline LDL | 3rd month LDL | |
| Metformin (002 Group) | 193.0 | 177.0 | 166.0 | 175.0 | 34.4 | 34.7 | 125.6 | 112.0 |
| Pioglitazone (001 Group) | 182.0 | 178 | 183 | 195 | 33 | 33.2 | 112.8 | 105.5 |
A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8. (NCT00595504)
Timeframe: Baseline and Week 8
| Intervention | g (Mean) |
|---|---|
| Ramelteon | 3934.86 |
| Placebo (Sugar Pill) | 5120.92 |
A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8. (NCT00595504)
Timeframe: Baseline and Week 8
| Intervention | HOMA score (Mean) |
|---|---|
| Ramelteon | 2.4 |
| Placebo (Sugar Pill) | 2.36 |
A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8. (NCT00595504)
Timeframe: Baseline and Week 8
| Intervention | cm (Mean) |
|---|---|
| Ramelteon | 106.09 |
| Placebo (Sugar Pill) | 108.37 |
(NCT01082588)
Timeframe: Baseline, week 12
| Intervention | mg/L (Mean) |
|---|---|
| Pravastatin | 0.8063 |
| Placebo | -0.5136 |
(NCT01082588)
Timeframe: Baseline, week 12
| Intervention | mg/dl (Mean) |
|---|---|
| Pravastatin | -25.565 |
| Placebo | -2.913 |
"The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.~The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning." (NCT01082588)
Timeframe: Baseline, week 12
| Intervention | Scores on a scale (Mean) |
|---|---|
| Pravastatin | 4.0417 |
| Placebo | 4.125 |
This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 15-105. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers. (NCT01082588)
Timeframe: Baseline, week 12
| Intervention | Scores on a scale (Mean) |
|---|---|
| Pravastatin | -5.625 |
| Placebo | -3.76 |
This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers. (NCT01082588)
Timeframe: Baseline, week 12
| Intervention | Scores on a scale (Mean) |
|---|---|
| Pravastatin | -0.83 |
| Placebo | -0.28 |
This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers. (NCT01082588)
Timeframe: Baseline, week 12
| Intervention | Scores on a scale (Mean) |
|---|---|
| Pravastatin | -2.9583 |
| Placebo | -2.44 |
The Positive and Negative Syndrome Scale (PANSS) is a scale used to rate severity of schizophrenia. All items are summed to calculate the total score. The scale range is 30-210. Better outcomes have lower numbers and worse outcomes have higher numbers. (NCT01082588)
Timeframe: Baseline, week 12
| Intervention | Scores on a scale (Mean) |
|---|---|
| Pravastatin | -9.416 |
| Placebo | -6.48 |
Change from baseline at Week 18 is defined as Week 18 minus Week 0. (NCT00337610)
Timeframe: Baseline and Week 18
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Sitagliptin 100 mg | -67.6 |
| Placebo | -13.5 |
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. (NCT00337610)
Timeframe: Baseline and Week 18
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Sitagliptin 100 mg | -1.00 |
| Placebo | 0.02 |
A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent. (NCT00337610)
Timeframe: Baseline and Week 30
| Intervention | Percent (Least Squares Mean) |
|---|---|
| Sitagliptin 100 mg | -0.98 |
| Placebo | 0.04 |
Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG. (NCT00337610)
Timeframe: Baseline and Week 18
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Sitagliptin 100 mg | -32.0 |
| Placebo | -6.5 |
The change from baseline is the Week 18 PMG minus the Week 0 PMG. (NCT00541775)
Timeframe: Baseline and 18 Weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Sitagliptin | -35.4 |
| Rosiglitazone | -51.3 |
| Placebo | -4.9 |
The change from baseline is the Week 18 FPG minus the Week 0 FPG. (NCT00541775)
Timeframe: Baseline and 18 Weeks
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Sitagliptin | -11.7 |
| Rosiglitazone | -24.5 |
| Placebo | 6.1 |
"A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.~The study hypothesis comparison was between sitagliptin versus placebo." (NCT00541775)
Timeframe: Baseline and 18 Weeks
| Intervention | Percent of glycosylated hemoglobin (A1C) (Least Squares Mean) |
|---|---|
| Sitagliptin | -0.73 |
| Rosiglitazone | -0.79 |
| Placebo | -0.22 |
To determine the concentration of metformin in adipose tissue. (NCT03477162)
Timeframe: Within 7 days from surgery
| Intervention | ng/g (Median) |
|---|---|
| Metformin | 70 |
To determine the concentration of metformin in plasma. (NCT03477162)
Timeframe: Within 7 days from surgery
| Intervention | ng/mL (Median) |
|---|---|
| Metformin | 450 |
To determine the concentration of metformin in tumor-adjacent normal tissue. (NCT03477162)
Timeframe: Within 7 days from surgery
| Intervention | ng/g (Median) |
|---|---|
| Metformin | 749 |
To determine the concentration of metformin in whole blood. (NCT03477162)
Timeframe: Within 7 days from surgery
| Intervention | ng/mL (Median) |
|---|---|
| Metformin | 514 |
To determine the intra-tumor concentrations of metformin, with a standard deviation ≤25% of the mean, in patients with solid tumors of thoracic origin administered metformin extended release. (NCT03477162)
Timeframe: Within 7 days from surgery
| Intervention | ng/g (Median) |
|---|---|
| Metformin | 1290 |
92 reviews available for metformin and Body Weight
| Article | Year |
|---|---|
Impact of pharmacological interventions on anthropometric indices in women with polycystic ovary syndrome: A systematic review and meta-analysis of randomized controlled trials.
Topics: Acarbose; Body Weight; Female; Humans; Hypoglycemic Agents; Metformin; Orlistat; Pioglitazone; Polyc | 2022 |
Efficacy and safety of combination therapy with vildagliptin and metformin vs. metformin monotherapy for Type 2 Diabetes Mellitus therapy: a meta-analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Diarrhea; Dizziness; Drug Therapy, Combinatio | 2022 |
Efficacy and Safety of Triple Therapy with SGLT-2 Inhibitor, DPP-4 Inhibitor, and Metformin in Type 2 Diabetes: A Meta-Analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Ther | 2023 |
Comparative efficacy and safety profile of once-weekly Semaglutide versus once-daily Sitagliptin as an add-on to metformin in patients with type 2 diabetes: a systematic review and meta-analysis.
Topics: Body Weight; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Metformin; | 2023 |
Comparison of the efficacy and safety of 10 glucagon-like peptide-1 receptor agonists as add-on to metformin in patients with type 2 diabetes: a systematic review.
Topics: Body Weight; Diabetes Mellitus, Type 2; Exenatide; Glucagon-Like Peptide-1 Receptor; Glycated Hemogl | 2023 |
Efficacy and safety of ipragliflozin as add-on to metformin for type 2 diabetes: a meta-analysis of double-blind randomized controlled trials.
Topics: Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug The | 2019 |
Diabetes drugs for nonalcoholic fatty liver disease: a systematic review.
Topics: Blood Glucose; Body Weight; Exenatide; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Liraglutide | 2019 |
Liraglutide: New Perspectives for the Treatment of Polycystic Ovary Syndrome.
Topics: Adult; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Humans; | 2020 |
Efficacy and safety of dapagliflozin plus saxagliptin vs monotherapy as added to metformin in patients with type 2 diabetes: A meta-analysis.
Topics: Adamantane; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Typ | 2020 |
Time course and dose effect of metformin on weight in patients with different disease states.
Topics: Antipsychotic Agents; Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Huma | 2020 |
Durability of glycaemic control in type 2 diabetes: A systematic review and meta-analysis for its association with body weight changes.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Ther | 2021 |
Effects of metformin on body weight in polycystic ovary syndrome patients: model-based meta-analysis.
Topics: Body Mass Index; Body Weight; Dose-Response Relationship, Drug; Female; Humans; Hypoglycemic Agents; | 2021 |
Is metformin effective for reducing weight in obese or overweight adolescents?
Topics: Adolescent; Body Mass Index; Body Weight; Humans; Hypoglycemic Agents; Metformin; Pediatric Obesity; | 2021 |
Efficacy of Various Hypoglycemic Agents in the Treatment of Patients With Nonalcoholic Liver Disease With or Without Diabetes： A Network Meta-Analysis.
Topics: Alanine Transaminase; Aspartate Aminotransferases; Bayes Theorem; Blood Glucose; Body Mass Index; Bo | 2021 |
Clinical Perspectives on the Use of Subcutaneous and Oral Formulations of Semaglutide.
Topics: Administration, Oral; Body Weight; Cardiovascular Diseases; Comorbidity; Decision Making; Diabetes M | 2021 |
Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force.
Topics: Adolescent; Advisory Committees; Anti-Obesity Agents; Body Mass Index; Body Weight; Child; Child, Pr | 2017 |
Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force.
Topics: Adolescent; Advisory Committees; Anti-Obesity Agents; Body Mass Index; Body Weight; Child; Child, Pr | 2017 |
Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force.
Topics: Adolescent; Advisory Committees; Anti-Obesity Agents; Body Mass Index; Body Weight; Child; Child, Pr | 2017 |
Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force.
Topics: Adolescent; Advisory Committees; Anti-Obesity Agents; Body Mass Index; Body Weight; Child; Child, Pr | 2017 |
Clinical implications of current cardiovascular outcome trials with sodium glucose cotransporter-2 (SGLT2) inhibitors.
Topics: Albuminuria; Atherosclerosis; Benzhydryl Compounds; Body Weight; Canagliflozin; Cardiovascular Disea | 2018 |
Understanding the impact of commonly utilized, non-insulin, glucose-lowering drugs on body weight in patients with type 2 diabetes.
Topics: Benzhydryl Compounds; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Ex | 2018 |
The safety of empagliflozin plus metformin for the treatment of type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2018 |
Comparison of antidiabetic drugs added to sulfonylurea monotherapy in patients with type 2 diabetes mellitus: A network meta-analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Comb | 2018 |
Topics: Body Weight; Child; Humans; Metformin; Obesity | 2018 |
Body Weight Considerations in the Management of Type 2 Diabetes.
Topics: Blood Glucose; Body Weight; Diabetes Complications; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase | 2019 |
Metformin induces significant reduction of body weight, total cholesterol and LDL levels in the elderly - A meta-analysis.
Topics: Aged; Aged, 80 and over; Anti-Obesity Agents; Anticholesteremic Agents; Body Weight; Cholesterol; Hu | 2018 |
Efficacy of Metformin Treatment with Respect to Weight Reduction in Children and Adults with Obesity: A Systematic Review.
Topics: Adult; Body Mass Index; Body Weight; Child; Diabetes Mellitus, Type 2; Dose-Response Relationship, D | 2018 |
Cost-effectiveness analysis of dapagliflozin treatment versus metformin treatment in Chinese population with type 2 diabetes.
Topics: Administration, Oral; Age Factors; Age of Onset; Benzhydryl Compounds; Body Weight; China; Cholester | 2019 |
Sodium-Glucose Co-Transporter 2 Inhibitors Compared with Sulfonylureas in Patients with Type 2 Diabetes Inadequately Controlled on Metformin: A Meta-Analysis of Randomized Controlled Trials.
Topics: Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Humans; Hypoglycemia; Hypogly | 2019 |
[Management of type 2 diabetes: new or previous agents, how to choose?].
Topics: Administration, Oral; Body Weight; Diabetes Complications; Diabetes Mellitus, Type 2; Dipeptidyl-Pep | 2013 |
Efficacy and safety of dipeptidyl peptidase-4 inhibitors and metformin as initial combination therapy and as monotherapy in patients with type 2 diabetes mellitus: a meta-analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Ther | 2014 |
Comparative effects of sitagliptin and metformin in patients with type 2 diabetes mellitus: a meta-analysis.
Topics: Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Humans; Hypoglycemic A | 2013 |
What are the preferred strategies for control of glycaemic variability in patients with type 2 diabetes mellitus?
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Diet, Reducing; Dipeptidyl-Peptidase IV Inhib | 2013 |
[SGLT-2 inhibitors: diabetes treatment by glycosuria; literature review on the effect of dapagliflozin].
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Glucosides; Glycated He | 2013 |
Dapagliflozin compared with other oral anti-diabetes treatments when added to metformin monotherapy: a systematic review and network meta-analysis.
Topics: Administration, Oral; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; D | 2014 |
[Oral add-on therapy to metformin in type 2 diabetes mellitus: a direct comparison between canagliflozin and sitagliptin].
Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Blood Pressure; Bod | 2014 |
Combinational therapy with metformin and sodium-glucose cotransporter inhibitors in management of type 2 diabetes: systematic review and meta-analyses.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabet | 2014 |
Efficacy and safety of basal insulin glargine 12 and 24 weeks after initiation in persons with type 2 diabetes: a pooled analysis of data from treatment arms of 15 treat-to-target randomised controlled trials.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; Glycated Hemoglobi | 2014 |
Comparative efficacy and safety of antidiabetic drug regimens added to metformin monotherapy in patients with type 2 diabetes: a network meta-analysis.
Topics: Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglob | 2015 |
[Metformin: new data for an old molecule].
Topics: Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Humans; Hypoglycemic | 2015 |
Evaluating the Effects of Metformin Use on Height in Children and Adolescents: A Meta-analysis of Randomized Clinical Trials.
Topics: Adolescent; Body Height; Body Mass Index; Body Weight; Child; Female; Humans; Hypoglycemic Agents; M | 2015 |
GLP-1 Receptor Agonists: Practical Considerations for Clinical Practice.
Topics: Blood Glucose; Blood Pressure; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Drug | 2015 |
Dipeptidyl Peptidase-4 Inhibitors in Diverse Patient Populations With Type 2 Diabetes.
Topics: Age Factors; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipepti | 2015 |
Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Exenatide; Glucagon-Like Peptides; Glycated H | 2016 |
Mono-ovulation in women with polycystic ovary syndrome: a clinical review on ovulation induction.
Topics: Adult; Anovulation; Body Weight; Clomiphene; Female; Fertility Agents, Female; Gonadotropins; Humans | 2016 |
Pharmacologic Therapy of Type 2 Diabetes.
Topics: Aging; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Dr | 2016 |
Metformin for Clozapine Associated Obesity: A Systematic Review and Meta-Analysis.
Topics: Antipsychotic Agents; Blood Glucose; Body Mass Index; Body Weight; Clozapine; Fasting; Humans; Hypog | 2016 |
Beneficial effect of lixisenatide after 76 weeks of treatment in patients with type 2 diabetes mellitus: A meta-analysis from the GetGoal programme.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Femal | 2017 |
Empagliflozin/metformin fixed-dose combination: a review in patients with type 2 diabetes.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Drug Co | 2016 |
Fixed-Dose Combination of Canagliflozin and Metformin for the Treatment of Type 2 Diabetes: An Overview.
Topics: Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Clinical Trials, Phase III as Topic; Diab | 2017 |
Combination treatment in the management of type 2 diabetes: focus on vildagliptin and metformin as a single tablet.
Topics: Adamantane; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Disease Prog | 2008 |
Drug evaluation: vildagliptin-metformin single-tablet combination.
Topics: Adamantane; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Combina | 2009 |
Metformin--the gold standard in type 2 diabetes: what does the evidence tell us?
Topics: Body Weight; Diabetes Mellitus, Type 2; Evidence-Based Medicine; Humans; Hypoglycemic Agents; Metfor | 2009 |
Diabetes medications and body weight.
Topics: Abdominal Fat; Benzamides; Body Weight; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Dipepti | 2009 |
Effects of pioglitazone and rosiglitazone combined with metformin on body weight in people with diabetes.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Humans; Hy | 2009 |
Changes in weight and metabolic parameters during treatment with antipsychotics and metformin: do the data inform as to potential guideline development? A systematic review of clinical studies.
Topics: Antipsychotic Agents; Appetite Depressants; Blood Glucose; Body Weight; Double-Blind Method; Humans; | 2009 |
The effect of metformin on anthropometrics and insulin resistance in patients receiving atypical antipsychotic agents: a meta-analysis.
Topics: Anthropometry; Antipsychotic Agents; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Humans | 2010 |
Thiazolidinediones plus metformin association on body weight in patients with type 2 diabetes.
Topics: Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Humans; Hypoglycemic Agents; Metf | 2011 |
The adjunctive use of metformin to treat or prevent atypical antipsychotic-induced weight gain: a review.
Topics: Antipsychotic Agents; Blood Glucose; Body Weight; Humans; Hypoglycemic Agents; Metformin; Obesity; O | 2010 |
Early clinical studies with liraglutide.
Topics: Blood Glucose; Body Weight; Cardiotonic Agents; Cardiovascular Diseases; Clinical Trials, Phase I as | 2010 |
Optimizing outcomes for GLP-1 agonists.
Topics: Algorithms; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Exenatide; Glucagon-Like Peptide | 2011 |
Weight beneficial treatments for type 2 diabetes.
Topics: Body Weight; Diabetes Mellitus, Type 2; Glucagon-Like Peptide 1; Humans; Hypoglycemic Agents; Insuli | 2011 |
Second-line therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a systematic review and mixed-treatment comparison meta-analysis.
Topics: Bayes Theorem; Body Weight; Confidence Intervals; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV | 2011 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Di | 2012 |
Effect of antidiabetic agents added to metformin on glycaemic control, hypoglycaemia and weight change in patients with type 2 diabetes: a network meta-analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobi | 2012 |
Metformin in obesity, cancer and aging: addressing controversies.
Topics: Aging; Animals; Body Weight; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemic Agents; Metform | 2012 |
Potential role of non-insulin adjunct therapy in Type 1 diabetes.
Topics: Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus, Type 1; Dipeptidyl-Peptidase IV Inhibitors | 2013 |
Incretin-based therapy in combination with basal insulin: a promising tactic for the treatment of type 2 diabetes.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Ther | 2013 |
Combination of drugs in the management of diabetes mellitus.
Topics: Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Humans; Hypogl | 2002 |
Reducing coronary heart disease associated with type 2 diabetes: lifestyle intervention and treatment of dyslipidaemia.
Topics: Body Weight; Clinical Trials as Topic; Coronary Disease; Diabetes Mellitus, Type 2; Drug Therapy, Co | 2003 |
Metformin in polycystic ovary syndrome: systematic review and meta-analysis.
Topics: Blood Pressure; Body Weight; Double-Blind Method; Female; Fertility Agents, Female; Humans; Insulin; | 2003 |
Treatment of insulin resistance in diabetes mellitus.
Topics: Anti-Inflammatory Agents; Body Weight; Diabetes Mellitus, Type 2; Female; Humans; Hyperglycemia; Hyp | 2004 |
Metformin in polycystic ovary syndrome.
Topics: Anovulation; Body Weight; Clomiphene; Drug Therapy, Combination; Female; Fertility Agents, Female; G | 2004 |
Tolerability profile of metformin/glibenclamide combination tablets (Glucovance): a new treatment for the management of type 2 diabetes mellitus.
Topics: Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Double-Blind Method; Drug | 2004 |
Treating insulin resistance in type 2 diabetes with metformin and thiazolidinediones.
Topics: Body Weight; Diabetes Mellitus, Type 2; Drug Monitoring; Drug Therapy, Combination; Humans; Hypergly | 2005 |
Insulin-sensitisers in the treatment of polycystic ovary syndrome.
Topics: Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diet; Drug Approval; Exercise; Fema | 2005 |
Pioglitazone: an antidiabetic drug with cardiovascular therapeutic effects.
Topics: Body Weight; Cardiovascular Diseases; Cardiovascular System; Diabetes Mellitus; Diabetic Angiopathie | 2006 |
Lifestyle choices, diet, and insulin sensitizers in polycystic ovary syndrome.
Topics: Age Factors; Alcohol Drinking; Body Weight; Caffeine; Female; Humans; Hypoglycemic Agents; Infertili | 2006 |
Lifestyle choices, diet, and insulin sensitizers in polycystic ovary syndrome.
Topics: Age Factors; Alcohol Drinking; Body Weight; Caffeine; Female; Humans; Hypoglycemic Agents; Infertili | 2006 |
Lifestyle choices, diet, and insulin sensitizers in polycystic ovary syndrome.
Topics: Age Factors; Alcohol Drinking; Body Weight; Caffeine; Female; Humans; Hypoglycemic Agents; Infertili | 2006 |
Lifestyle choices, diet, and insulin sensitizers in polycystic ovary syndrome.
Topics: Age Factors; Alcohol Drinking; Body Weight; Caffeine; Female; Humans; Hypoglycemic Agents; Infertili | 2006 |
Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin. Effect of body weight, gender, and race on systemic exposures of each drug.
Topics: Administration, Oral; Adult; Area Under Curve; Biological Availability; Black People; Body Weight; D | 2007 |
[Diabetes type 2 in pediatrics: diagnosis and management].
Topics: Adolescent; Body Weight; Child; Child, Preschool; Diabetes Complications; Diabetes Mellitus, Type 2; | 2007 |
Metformin and body weight.
Topics: Adolescent; Adult; Body Weight; Child; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemic Agent | 2008 |
DPP-4 inhibitors.
Topics: Adamantane; Animals; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Dru | 2007 |
Cardiovascular risk in women with polycystic ovary syndrome.
Topics: Atherosclerosis; Biomarkers; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Exerci | 2007 |
Management of type 2 diabetes in the obese patient: current concerns and emerging therapies.
Topics: Anti-Obesity Agents; Body Weight; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Incretins; | 2008 |
Pharmacotherapy for obesity.
Topics: Amyloid; Anti-Obesity Agents; Appetite Depressants; Body Weight; Chronic Disease; Comorbidity; Cyclo | 2007 |
Glycaemic control and adverse events in patients with type 2 diabetes treated with metformin + sulphonylurea: a meta-analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glycated Hemoglobi | 2008 |
Role of metformin for weight management in patients without type 2 diabetes.
Topics: Adolescent; Adult; Anti-Obesity Agents; Body Weight; Clinical Trials as Topic; Humans; Hypoglycemic | 2008 |
[The value of metformin in therapy of type 2 diabetes: effect on insulin resistance, diabetic control and cardiovascular risk factors].
Topics: Blood Glucose; Body Weight; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Diabetic Angiopathi | 1994 |
Worldwide experience of metformin as an effective glucose-lowering agent: a meta-analysis.
Topics: Body Weight; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Metformin | 1995 |
Efficacy of metformin in the treatment of NIDDM. Meta-analysis.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Humans; Hypoglycemic Age | 1999 |
A risk-benefit assessment of metformin in type 2 diabetes mellitus.
Topics: Acidosis, Lactic; Body Weight; Contraindications; Diabetes Mellitus, Type 2; Female; Glucose; Humans | 1999 |
Should patients with polycystic ovarian syndrome be treated with metformin? A note of cautious optimism.
Topics: Anovulation; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Female; Gastrointestin | 2002 |
Metformin: a review of its pharmacological properties and therapeutic use.
Topics: Animals; Body Weight; Diabetes Mellitus; Gluconeogenesis; Glucose; Glycogen; Humans; Insulin; Insuli | 1979 |
Glucose tolerance tests in the clinical picture of chronic liver diseases.
Topics: Adolescent; Adult; Age Factors; Aged; Alanine Transaminase; Aspartate Aminotransferases; Body Weight | 1975 |
[Glycemic equilibrium and weight evolution in diabetics taking metformin].
Topics: Blood Glucose; Body Weight; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Humans; Meta-Analys | 1991 |
266 trials available for metformin and Body Weight
| Article | Year |
|---|---|
Metformin maintains intrahepatic triglyceride content through increased hepatic de novo lipogenesis.
Topics: Adult; Body Weight; Cohort Studies; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemic Agents; | 2022 |
Fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) improves ß-cell function in people with type 2 diabetes.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Combinations; Glucagon-Like Peptide-1 Re | 2022 |
Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Glucagon-Li | 2022 |
Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Com | 2022 |
Efficacy and safety of janagliflozin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therap | 2023 |
Efficacy and safety of janagliflozin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therap | 2023 |
Efficacy and safety of janagliflozin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therap | 2023 |
Efficacy and safety of janagliflozin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therap | 2023 |
Efficacy and safety of janagliflozin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therap | 2023 |
Efficacy and safety of janagliflozin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therap | 2023 |
Efficacy and safety of janagliflozin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therap | 2023 |
Efficacy and safety of janagliflozin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therap | 2023 |
Efficacy and safety of janagliflozin as add-on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double-blind, placebo-controlled, phase 3 trial.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therap | 2023 |
Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change).
Topics: Adult; Body Weight; Diabetes Mellitus, Type 2; Economics, Behavioral; Humans; Metformin; Motivation; | 2023 |
Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change).
Topics: Adult; Body Weight; Diabetes Mellitus, Type 2; Economics, Behavioral; Humans; Metformin; Motivation; | 2023 |
Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change).
Topics: Adult; Body Weight; Diabetes Mellitus, Type 2; Economics, Behavioral; Humans; Metformin; Motivation; | 2023 |
Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change).
Topics: Adult; Body Weight; Diabetes Mellitus, Type 2; Economics, Behavioral; Humans; Metformin; Motivation; | 2023 |
Short-term effect of polyethylene glycol loxenatide on weight loss in overweight or obese patients with type 2 diabetes: An open-label, parallel-arm, randomized, metformin-controlled trial.
Topics: Body Weight; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Metformin; Obesity; Overweight; | 2023 |
Effectiveness and safety of Daixie Decoction granules combined with metformin for the treatment of T2DM patients with obesity: study protocol for a randomized, double-blinded, placebo-controlled, multicentre clinical trial.
Topics: Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Humans; Metformin; Multicenter Studies | 2023 |
Adding empagliflozin to sitagliptin plus metformin vs. adding sitagliptin to empagliflozin plus metformin as triple therapy in Egyptian patients with type 2 diabetes: a 12-week open trial.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Egypt; Glycated Hemoglobin; Humans; Metformin | 2023 |
Predictors of ≥15% Weight Reduction and Associated Changes in Cardiometabolic Risk Factors With Tirzepatide in Adults With Type 2 Diabetes in SURPASS 1-4.
Topics: Adult; Blood Glucose; Body Weight; Cardiometabolic Risk Factors; Cholesterol; Diabetes Mellitus, Typ | 2023 |
Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial.
Topics: Adult; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Femal | 2019 |
Metformin blunts muscle hypertrophy in response to progressive resistance exercise training in older adults: A randomized, double-blind, placebo-controlled, multicenter trial: The MASTERS trial.
Topics: Aged; Aged, 80 and over; Body Composition; Body Weight; Cells, Cultured; Double-Blind Method; Exerci | 2019 |
Effects of metformin administration on endocrine-metabolic parameters, visceral adiposity and cardiovascular risk factors in children with obesity and risk markers for metabolic syndrome: A pilot study.
Topics: Adolescent; Body Mass Index; Body Weight; C-Reactive Protein; Carotid Intima-Media Thickness; Child; | 2019 |
GDF15 mediates the effects of metformin on body weight and energy balance.
Topics: Administration, Oral; Adult; Aged; Animals; Blood Glucose; Body Weight; Diet, High-Fat; Double-Blind | 2020 |
Efficacy and safety of dapagliflozin plus saxagliptin versus insulin glargine over 52 weeks as add-on to metformin with or without sulphonylurea in patients with type 2 diabetes: A randomized, parallel-design, open-label, Phase 3 trial.
Topics: Adamantane; Adult; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipe | 2020 |
Metformin Lowers Body Weight But Fails to Increase Insulin Sensitivity in Chronic Heart Failure Patients without Diabetes: a Randomized, Double-Blind, Placebo-Controlled Study.
Topics: Aged; Body Composition; Body Weight; Calorimetry, Indirect; Double-Blind Method; Female; Glucagon; G | 2021 |
Liraglutide or insulin glargine treatments improves hepatic fat in obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks: A randomized placebo-controlled trial.
Topics: Adult; Blood Glucose; Body Weight; China; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fema | 2020 |
Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Met | 2021 |
Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Met | 2021 |
Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Met | 2021 |
Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Met | 2021 |
Liraglutide and sitagliptin have no effect on intestinal microbiota composition: A 12-week randomized placebo-controlled trial in adults with type 2 diabetes.
Topics: Adult; Aged; Bile Acids and Salts; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV I | 2021 |
Dapagliflozin increases the lean-to total mass ratio in type 2 diabetes mellitus.
Topics: Absorptiometry, Photon; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Composition; Body Wei | 2021 |
Danuglipron (PF-06882961) in type 2 diabetes: a randomized, placebo-controlled, multiple ascending-dose phase 1 trial.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Glucagon-Like Peptide-1 Rece | 2021 |
A 24-month metformin treatment study of children with obesity: Changes in circulating GDF-15 and associations with changes in body weight and visceral fat.
Topics: Body Mass Index; Body Weight; Child; Double-Blind Method; Growth Differentiation Factor 15; Humans; | 2022 |
Protocol for a randomised controlled trial of the effect of dapagliflozin, metformin and exercise on glycaemic variability, body composition and cardiovascular risk in prediabetes (the PRE-D Trial).
Topics: Adult; Aged; Benzhydryl Compounds; Body Composition; Body Weight; Cardiovascular Diseases; Denmark; | 2017 |
Protocol for a randomised controlled trial of the effect of dapagliflozin, metformin and exercise on glycaemic variability, body composition and cardiovascular risk in prediabetes (the PRE-D Trial).
Topics: Adult; Aged; Benzhydryl Compounds; Body Composition; Body Weight; Cardiovascular Diseases; Denmark; | 2017 |
Protocol for a randomised controlled trial of the effect of dapagliflozin, metformin and exercise on glycaemic variability, body composition and cardiovascular risk in prediabetes (the PRE-D Trial).
Topics: Adult; Aged; Benzhydryl Compounds; Body Composition; Body Weight; Cardiovascular Diseases; Denmark; | 2017 |
Protocol for a randomised controlled trial of the effect of dapagliflozin, metformin and exercise on glycaemic variability, body composition and cardiovascular risk in prediabetes (the PRE-D Trial).
Topics: Adult; Aged; Benzhydryl Compounds; Body Composition; Body Weight; Cardiovascular Diseases; Denmark; | 2017 |
Patient-reported Outcomes in Patients with Type 2 Diabetes Treated with Dulaglutide Added to Titrated Insulin Glargine (AWARD-9).
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Glucagon-L | 2017 |
Safety and efficacy of metformin up-titration in Japanese patients with type 2 diabetes mellitus treated with vildagliptin and low-dose metformin.
Topics: Adamantane; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; | 2017 |
Effects of exenatide once weekly plus dapagliflozin, exenatide once weekly, or dapagliflozin, added to metformin monotherapy, on body weight, systolic blood pressure, and triglycerides in patients with type 2 diabetes in the DURATION-8 study.
Topics: Anti-Obesity Agents; Benzhydryl Compounds; Blood Pressure; Body Mass Index; Body Weight; Diabetes Me | 2018 |
CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine.
Topics: Antipsychotic Agents; Body Mass Index; Body Weight; Clozapine; Diabetes Mellitus, Type 2; Double-Bli | 2018 |
Effects of exenatide once weekly plus dapagliflozin, exenatide once weekly alone, or dapagliflozin alone added to metformin monotherapy in subgroups of patients with type 2 diabetes in the DURATION-8 randomized controlled trial.
Topics: Administration, Oral; Adult; Aged; Benzhydryl Compounds; Body Weight; Diabetes Mellitus, Type 2; Dru | 2018 |
Efficacy and safety of Sancai powder in patients with type 2 diabetes mellitus: a randomized controlled trial.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drugs, Chinese Herbal; Female; G | 2016 |
High-Dose, Diazoxide-Mediated Insulin Suppression Boosts Weight Loss Induced by Lifestyle Intervention.
Topics: Adult; Blood Glucose; Body Mass Index; Body Weight; Diazoxide; Dose-Response Relationship, Drug; Dou | 2018 |
Dapagliflozin versus saxagliptin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin.
Topics: Adamantane; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Typ | 2018 |
Liraglutide, Sitagliptin, and Insulin Glargine Added to Metformin: The Effect on Body Weight and Intrahepatic Lipid in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease.
Topics: Adult; Aged; Blood Glucose; Body Weight; Comorbidity; Diabetes Mellitus, Type 2; Dose-Response Relat | 2019 |
A whey/guar "preload" improves postprandial glycaemia and glycated haemoglobin levels in type 2 diabetes: A 12-week, single-blind, randomized, placebo-controlled trial.
Topics: Aged; Blood Glucose; Body Composition; Body Weight; Diabetes Mellitus, Type 2; Diet, Diabetic; Energ | 2019 |
Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centr
Topics: Adamantane; Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptides; Female; | 2019 |
Randomized Controlled Trial of a Leucine-Metformin-Sildenafil Combination (NS-0200) on Weight and Metabolic Parameters.
Topics: Body Weight; Double-Blind Method; Female; Humans; Hypoglycemic Agents; Leucine; Male; Metformin; Mid | 2019 |
Effect of intensive lifestyle modification & metformin on cardiovascular risk in prediabetes: A pilot randomized control trial.
Topics: Adult; Blood Glucose; Body Weight; C-Reactive Protein; Cardiovascular Diseases; Carotid Intima-Media | 2018 |
A randomized controlled trial of metformin on left ventricular hypertrophy in patients with coronary artery disease without diabetes: the MET-REMODEL trial.
Topics: Aged; Body Weight; Coronary Artery Disease; Female; Heart Ventricles; Humans; Hypertrophy, Left Vent | 2019 |
Triple therapy with low-dose dapagliflozin plus saxagliptin versus dual therapy with each monocomponent, all added to metformin, in uncontrolled type 2 diabetes.
Topics: Adamantane; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptides; | 2019 |
Effect of Nigella Sativa oil versus metformin on glycemic control and biochemical parameters of newly diagnosed type 2 diabetes mellitus patients.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemic Agents; Male; Me | 2019 |
Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes.
Topics: Argentina; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Drug Administrati | 2013 |
Sitagliptin as add-on therapy in insulin deficiency: biomarkers of therapeutic efficacy respond differently in type 1 and type 2 diabetes.
Topics: Adult; Aged; Biomarkers; Blood Glucose; Body Weight; Cholesterol, LDL; Diabetes Mellitus, Type 1; Di | 2013 |
Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients: phase IV open-label trial.
Topics: Adult; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemo | 2013 |
Ultrasonography modifications of visceral and subcutaneous adipose tissue after pioglitazone or glibenclamide therapy combined with rosuvastatin in type 2 diabetic patients not well controlled by metformin.
Topics: Adipokines; Aged; Biomarkers; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2 | 2013 |
[Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin].
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dose-Response Rel | 2013 |
[Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin].
Topics: Aged; Balanitis; Benzhydryl Compounds; Blood Glucose; Body Weight; Candidiasis, Vulvovaginal; Diabet | 2013 |
Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Exenatide; Humans; H | 2013 |
Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study.
Topics: Body Mass Index; Body Weight; Cohort Studies; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; | 2014 |
Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study.
Topics: Body Mass Index; Body Weight; Cohort Studies; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; | 2014 |
Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study.
Topics: Body Mass Index; Body Weight; Cohort Studies; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; | 2014 |
Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study.
Topics: Body Mass Index; Body Weight; Cohort Studies; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; | 2014 |
Variation in inflammatory markers and glycemic parameters after 12 months of exenatide plus metformin treatment compared with metformin alone: a randomized placebo-controlled trial.
Topics: Aged; Arginine; Biomarkers; Blood Glucose; Body Mass Index; Body Weight; C-Peptide; Chimerin Protein | 2013 |
Effects of adjunctive metformin on metabolic traits in nondiabetic clozapine-treated patients with schizophrenia and the effect of metformin discontinuation on body weight: a 24-week, randomized, double-blind, placebo-controlled study.
Topics: Adult; Body Weight; Clozapine; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Metabol | 2013 |
Empagliflozin improves glycaemic and weight control as add-on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes: a 24-week, randomized, placebo-controlled trial.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Meth | 2014 |
Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Ty | 2013 |
Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Ty | 2013 |
Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Ty | 2013 |
Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Ty | 2013 |
Acarbose plus metformin fixed-dose combination outperforms acarbose monotherapy for type 2 diabetes.
Topics: Acarbose; Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Combinations; Fem | 2013 |
Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial.
Topics: Adolescent; Aged; Aged, 80 and over; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diab | 2013 |
Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial.
Topics: Adolescent; Aged; Aged, 80 and over; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diab | 2013 |
Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial.
Topics: Adolescent; Aged; Aged, 80 and over; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diab | 2013 |
Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial.
Topics: Adolescent; Aged; Aged, 80 and over; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diab | 2013 |
[A combination of dipeptidyl peptidase-4 inhibitor and metformin in the treatment of patients with type 2 diabetes mellitus: effective control of glycemia, weight, and quantitative body composition].
Topics: Absorptiometry, Photon; Adamantane; Blood Glucose; Body Composition; Body Mass Index; Body Weight; D | 2013 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double- | 2014 |
Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.
Topics: Adamantane; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitu | 2014 |
Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.
Topics: Adamantane; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitu | 2014 |
Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.
Topics: Adamantane; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitu | 2014 |
Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.
Topics: Adamantane; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitu | 2014 |
A randomized controlled trial of the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes and inadequate glycaemic control on metformin plus a sulphonylurea.
Topics: Adamantane; Adult; Australia; Blood Glucose; Body Mass Index; Body Weight; Canada; Diabetes Mellitus | 2014 |
Dose response of continuous subcutaneous infusion of recombinant glucagon-like peptide-1 in combination with metformin and sulphonylurea over 12 weeks in patients with type 2 diabetes mellitus.
Topics: Adult; Aged; Aged, 80 and over; Analysis of Variance; Blood Glucose; Body Weight; Diabetes Mellitus, | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
Topics: Adult; Body Weight; Female; Glucagon-Like Peptide 1; Glucagon-Like Peptide-1 Receptor; Humans; Lirag | 2014 |
Urinary tract infection in randomized phase III studies of canagliflozin, a sodium glucose co-transporter 2 inhibitor.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Blood Pressure; Body Weight; Canagliflozi | 2014 |
Efficacy and safety of initial combination therapy with alogliptin plus metformin versus either as monotherapy in drug-naïve patients with type 2 diabetes: a randomized, double-blind, 6-month study.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combinatio | 2014 |
Exenatide improves type 2 diabetes concomitant with non-alcoholic fatty liver disease.
Topics: Adiponectin; Adult; Aged; Alanine Transaminase; Blood Glucose; Body Mass Index; Body Weight; C-React | 2013 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucagon; Gluc | 2014 |
Effects of short-term metformin therapy associated with levothyroxine dose decrement on TSH and thyroid hormone levels in patients with thyroid cancer.
Topics: Adenocarcinoma, Follicular; Adult; Body Weight; Carcinoma, Papillary; Dose-Response Relationship, Dr | 2014 |
The effects of dipeptidyl peptidase-4 inhibitors in treatment of obese patients with type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Mass Index; Body Weight; Cholesterol, LDL; Diabetes | 2013 |
Empagliflozin as add-on to metformin in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Cohort Studies; Diabetes Mellitus, | 2014 |
Phosphodiesterase 4 inhibition as a potential new therapeutic target in obese women with polycystic ovary syndrome.
Topics: Adult; Aminopyridines; Benzamides; Body Weight; Cyclopropanes; Drug-Related Side Effects and Adverse | 2014 |
Lifestyle and metformin interventions have a durable effect to lower CRP and tPA levels in the diabetes prevention program except in those who develop diabetes.
Topics: Adult; Aged; Aged, 80 and over; Body Weight; C-Reactive Protein; Diabetes Mellitus, Type 2; Female; | 2014 |
Safety, efficacy and weight effect of two 11β-HSD1 inhibitors in metformin-treated patients with type 2 diabetes.
Topics: 11-beta-Hydroxysteroid Dehydrogenase Type 1; Adult; Aged; Austria; Blood Glucose; Body Weight; C-Pep | 2014 |
Efficacy and safety comparison of add-on therapy with liraglutide, saxagliptin and vildagliptin, all in combination with current conventional oral hypoglycemic agents therapy in poorly controlled Chinese type 2 diabetes.
Topics: Adamantane; Adult; Asian People; Blood Glucose; Body Weight; China; Diabetes Mellitus, Type 2; Dipep | 2014 |
Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3).
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Glu | 2014 |
Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3).
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Glu | 2014 |
Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3).
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Glu | 2014 |
Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3).
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Glu | 2014 |
HARMONY 3: 104-week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin.
Topics: Aged; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Female | 2014 |
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re | 2014 |
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re | 2014 |
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re | 2014 |
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re | 2014 |
Ipragliflozin in combination with metformin for the treatment of Japanese patients with type 2 diabetes: ILLUMINATE, a randomized, double-blind, placebo-controlled study.
Topics: Aged; Asian People; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug | 2015 |
Effect of the sodium glucose co-transporter 2 inhibitor canagliflozin on plasma volume in patients with type 2 diabetes mellitus.
Topics: Adult; Aged; Antihypertensive Agents; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Dia | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide | 2014 |
Twice-daily dapagliflozin co-administered with metformin in type 2 diabetes: a 16-week randomized, placebo-controlled clinical trial.
Topics: Aged; Benzhydryl Compounds; Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug | 2015 |
Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study.
Topics: Blood Glucose; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Ther | 2015 |
Weight loss increases follicle stimulating hormone in overweight postmenopausal women [corrected].
Topics: Aged; Behavior Therapy; Body Weight; Diabetes Mellitus, Type 2; Estradiol; Female; Follicle Stimulat | 2015 |
[Efficacy of metformin in abdominal obesity].
Topics: Adult; Blood Pressure; Body Mass Index; Body Weight; Female; Humans; Hypoglycemic Agents; Insulin Re | 2014 |
Comparison of insulin glargine and liraglutide added to oral agents in patients with poorly controlled type 2 diabetes.
Topics: Administration, Oral; Aged; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; | 2015 |
Efficacy and safety of dapagliflozin monotherapy in people with Type 2 diabetes: a randomized double-blind placebo-controlled 102-week trial.
Topics: Adolescent; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2 | 2015 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials.
Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D | 2014 |
Long-term efficacy and safety of canagliflozin over 104 weeks in patients aged 55-80 years with type 2 diabetes.
Topics: Aged; Aged, 80 and over; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Cholesterol, HDL | 2015 |
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2015 |
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2015 |
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2015 |
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2015 |
Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D | 2015 |
Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Bridged Bicyclo Compounds, Heterocyclic; Di | 2015 |
Design of FLAT-SUGAR: Randomized Trial of Prandial Insulin Versus Prandial GLP-1 Receptor Agonist Together With Basal Insulin and Metformin for High-Risk Type 2 Diabetes.
Topics: Albuminuria; Biomarkers; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Diabetic Angiopathie | 2015 |
The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial.
Topics: Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Drugs, Chine | 2015 |
Empagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Ty | 2015 |
Empagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Ty | 2015 |
Empagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Ty | 2015 |
Empagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Ty | 2015 |
A novel and selective sodium-glucose cotransporter-2 inhibitor, tofogliflozin, improves glycaemic control and lowers body weight in patients with type 2 diabetes mellitus.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Combined Modality The | 2015 |
Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial.
Topics: Aged; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Dr | 2015 |
Durability and tolerability of dapagliflozin over 52 weeks as add-on to metformin and sulphonylurea in type 2 diabetes.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Cholesterol; Diabetes Mellit | 2015 |
Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Ty | 2015 |
Effects of Liraglutide Monotherapy on Beta Cell Function and Pancreatic Enzymes Compared with Metformin in Japanese Overweight/Obese Patients with Type 2 Diabetes Mellitus: A Subpopulation Analysis of the KIND-LM Randomized Trial.
Topics: Amylases; Blood Glucose; Body Fat Distribution; Body Weight; Diabetes Mellitus, Type 2; Drug Adminis | 2015 |
The effects of metformin treatment of gestational diabetes on maternal weight and glucose tolerance postpartum--a prospective follow-up study.
Topics: Adult; Blood Glucose; Body Weight; Diabetes, Gestational; Female; Follow-Up Studies; Glucose Toleran | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; D | 2016 |
Efficacy and safety of dapagliflozin in Asian patients with type 2 diabetes after metformin failure: A randomized controlled trial.
Topics: Adult; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; | 2016 |
Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial.
Topics: Adolescent; Blood Glucose; Body Mass Index; Body Weight; Child; Diabetes Mellitus, Type 1; Double-Bl | 2015 |
Metformin treatment of antipsychotic-induced dyslipidemia: an analysis of two randomized, placebo-controlled trials.
Topics: Adult; Antipsychotic Agents; Blood Glucose; Body Weight; Double-Blind Method; Dyslipidemias; Female; | 2016 |
Metformin versus placebo in combination with insulin analogues in patients with type 2 diabetes mellitus-the randomised, blinded Copenhagen Insulin and Metformin Therapy (CIMT) trial.
Topics: Blood Glucose; Body Weight; Carotid Intima-Media Thickness; Denmark; Diabetes Mellitus, Type 2; Glyc | 2016 |
Effects of biphasic, basal-bolus or basal insulin analogue treatments on carotid intima-media thickness in patients with type 2 diabetes mellitus: the randomised Copenhagen Insulin and Metformin Therapy (CIMT) trial.
Topics: Blood Glucose; Body Weight; Carotid Intima-Media Thickness; Denmark; Diabetes Mellitus, Type 2; Drug | 2016 |
Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anorexia; Asian People; Blood Glucose; Body Weight; Chin | 2016 |
Safety, tolerability, pharmacokinetics and pharmacodynamics of AZP-531, a first-in-class analogue of unacylated ghrelin, in healthy and overweight/obese subjects and subjects with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Diarrhea; Double-Bli | 2016 |
Weight and Glucose Reduction Observed with a Combination of Nutritional Agents in Rodent Models Does Not Translate to Humans in a Randomized Clinical Trial with Healthy Volunteers and Subjects with Type 2 Diabetes.
Topics: Adolescent; Adult; Aged; Animals; Biological Factors; Blood Glucose; Body Weight; Diabetes Mellitus, | 2016 |
Comparative evaluation of the therapeutic effect of metformin monotherapy with metformin and acupuncture combined therapy on weight loss and insulin sensitivity in diabetic patients.
Topics: Acupuncture Therapy; Adiponectin; Adult; Biomarkers; Body Mass Index; Body Weight; Cholesterol, HDL; | 2016 |
Efficacy and safety of titrated canagliflozin in patients with type 2 diabetes mellitus inadequately controlled on metformin and sitagliptin.
Topics: Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; Double-B | 2016 |
Weight change in the management of youth-onset type 2 diabetes: the TODAY clinical trial experience.
Topics: Adolescent; Anthropometry; Blood Glucose; Body Weight; Child; Diabetes Mellitus, Type 2; Drug Combin | 2017 |
Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk.
Topics: Adult; Aged; Alanine Transaminase; Arrhythmias, Cardiac; Blood Glucose; Body Weight; Cardiovascular | 2016 |
Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk.
Topics: Adult; Aged; Alanine Transaminase; Arrhythmias, Cardiac; Blood Glucose; Body Weight; Cardiovascular | 2016 |
Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk.
Topics: Adult; Aged; Alanine Transaminase; Arrhythmias, Cardiac; Blood Glucose; Body Weight; Cardiovascular | 2016 |
Glucose Variability in a 26-Week Randomized Comparison of Mealtime Treatment With Rapid-Acting Insulin Versus GLP-1 Agonist in Participants With Type 2 Diabetes at High Cardiovascular Risk.
Topics: Adult; Aged; Alanine Transaminase; Arrhythmias, Cardiac; Blood Glucose; Body Weight; Cardiovascular | 2016 |
Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial.
Topics: Aged; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combinat | 2016 |
Efficacy and safety of sitagliptin/metformin fixed-dose combination compared with glimepiride in patients with type 2 diabetes: A multicenter randomized double-blind study.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Diarrhea; Double-Blind Method; Drug Th | 2017 |
Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Lixisenatide and Insulin Glargine, Versus Insulin Glargine in Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy: The LixiLan Proof-of-Concept Randomized Trial.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Combinations; Drug Therapy, Combin | 2016 |
Once-Daily Liraglutide Versus Lixisenatide as Add-on to Metformin in Type 2 Diabetes: A 26-Week Randomized Controlled Clinical Trial.
Topics: Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administ | 2016 |
Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial.
Topics: Adult; Aged; Aged, 80 and over; Asia; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double- | 2016 |
Efficacy and safety of triple therapy with dapagliflozin add-on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes.
Topics: Adamantane; Adult; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipe | 2016 |
Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Body Mass Index; Body Weight; Canagliflozin; Diabetes Mellitus, Type | 2016 |
Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Body Mass Index; Body Weight; Canagliflozin; Diabetes Mellitus, Type | 2016 |
Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Body Mass Index; Body Weight; Canagliflozin; Diabetes Mellitus, Type | 2016 |
Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Body Mass Index; Body Weight; Canagliflozin; Diabetes Mellitus, Type | 2016 |
One-year efficacy and safety of saxagliptin add-on in patients receiving dapagliflozin and metformin.
Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2 | 2016 |
Effects of SLC22A1 Polymorphisms on Metformin-Induced Reductions in Adiposity and Metformin Pharmacokinetics in Obese Children With Insulin Resistance.
Topics: Adiposity; Body Weight; Child; Double-Blind Method; Female; Genotype; Glomerular Filtration Rate; Hu | 2017 |
Phase II study of metformin for reduction of obesity-associated breast cancer risk: a randomized controlled trial protocol.
Topics: Adiponectin; Adult; Body Weight; Breast; Breast Neoplasms; Double-Blind Method; Humans; Hypoglycemic | 2016 |
Pharmacodynamic Effects of Single and Multiple Doses of Empagliflozin in Patients With Type 2 Diabetes.
Topics: Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Weight; Cross-Over Studies; Diabetes Mellitus | 2016 |
The effects of exenatide twice daily compared to insulin lispro added to basal insulin in Latin American patients with type 2 diabetes: A retrospective analysis of the 4B trial.
Topics: Adult; Aged; Argentina; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration S | 2016 |
Sustained influence of metformin therapy on circulating glucagon-like peptide-1 levels in individuals with and without type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Body Weight; Case-Control Studies; Diabetes Mellitus, Type 2; Double-Bli | 2017 |
Metformin in adults with type 1 diabetes: Design and methods of REducing with MetfOrmin Vascular Adverse Lesions (REMOVAL): An international multicentre trial.
Topics: Adult; Atherosclerosis; Blood Glucose; Body Weight; Carotid Intima-Media Thickness; Cholesterol, LDL | 2017 |
Effects of Low Dose Metformin on Metabolic Traits in Clozapine-Treated Schizophrenia Patients: An Exploratory Twelve-Week Randomized, Double-Blind, Placebo-Controlled Study.
Topics: Adult; Antipsychotic Agents; Body Mass Index; Body Weight; Clozapine; Double-Blind Method; Female; H | 2016 |
Effects of Low Dose Metformin on Metabolic Traits in Clozapine-Treated Schizophrenia Patients: An Exploratory Twelve-Week Randomized, Double-Blind, Placebo-Controlled Study.
Topics: Adult; Antipsychotic Agents; Body Mass Index; Body Weight; Clozapine; Double-Blind Method; Female; H | 2016 |
Effects of Low Dose Metformin on Metabolic Traits in Clozapine-Treated Schizophrenia Patients: An Exploratory Twelve-Week Randomized, Double-Blind, Placebo-Controlled Study.
Topics: Adult; Antipsychotic Agents; Body Mass Index; Body Weight; Clozapine; Double-Blind Method; Female; H | 2016 |
Effects of Low Dose Metformin on Metabolic Traits in Clozapine-Treated Schizophrenia Patients: An Exploratory Twelve-Week Randomized, Double-Blind, Placebo-Controlled Study.
Topics: Adult; Antipsychotic Agents; Body Mass Index; Body Weight; Clozapine; Double-Blind Method; Female; H | 2016 |
Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial.
Topics: Adult; Biomarkers; Blood Glucose; Body Weight; Drug Therapy, Combination; Female; Follow-Up Studies; | 2017 |
Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial.
Topics: Adult; Biomarkers; Blood Glucose; Body Weight; Drug Therapy, Combination; Female; Follow-Up Studies; | 2017 |
Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial.
Topics: Adult; Biomarkers; Blood Glucose; Body Weight; Drug Therapy, Combination; Female; Follow-Up Studies; | 2017 |
Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial.
Topics: Adult; Biomarkers; Blood Glucose; Body Weight; Drug Therapy, Combination; Female; Follow-Up Studies; | 2017 |
Use of metformin in obese adolescents with hyperinsulinemia: a 6-month, randomized, double-blind, placebo-controlled clinical trial.
Topics: Adolescent; Body Weight; Child; Double-Blind Method; Female; Humans; Hyperinsulinism; Hypoglycemic A | 2008 |
Metformin improves endothelial function in normoinsulinemic PCOS patients: a new prospective.
Topics: Adult; Androgens; Body Weight; Brachial Artery; Endothelium, Vascular; Female; Humans; Insulin; Metf | 2008 |
Treatment of non-alcoholic fatty liver disease with metformin versus lifestyle intervention in insulin-resistant adolescents.
Topics: Adolescent; Alanine Transaminase; Aspartate Aminotransferases; Body Mass Index; Body Weight; Child; | 2009 |
Treatment of non-alcoholic fatty liver disease with metformin versus lifestyle intervention in insulin-resistant adolescents.
Topics: Adolescent; Alanine Transaminase; Aspartate Aminotransferases; Body Mass Index; Body Weight; Child; | 2009 |
Treatment of non-alcoholic fatty liver disease with metformin versus lifestyle intervention in insulin-resistant adolescents.
Topics: Adolescent; Alanine Transaminase; Aspartate Aminotransferases; Body Mass Index; Body Weight; Child; | 2009 |
Treatment of non-alcoholic fatty liver disease with metformin versus lifestyle intervention in insulin-resistant adolescents.
Topics: Adolescent; Alanine Transaminase; Aspartate Aminotransferases; Body Mass Index; Body Weight; Child; | 2009 |
Effect of adjunct metformin treatment in patients with type-1 diabetes and persistent inadequate glycaemic control. A randomized study.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 1; Female; Glycated Hemoglobin; Humans; H | 2008 |
Antiandrogenic contraceptives increase serum adiponectin in obese polycystic ovary syndrome patients.
Topics: Adipocytes; Adiponectin; Adipose Tissue; Adult; Androgen Antagonists; Area Under Curve; Body Weight; | 2009 |
Fifty-two-week efficacy and safety of vildagliptin vs. glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy.
Topics: Adamantane; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Adminis | 2009 |
Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trial.
Topics: Adamantane; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptid | 2009 |
Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial.
Topics: Administration, Oral; Angina, Unstable; Body Weight; Cholesterol, HDL; Cholesterol, LDL; Diabetes Me | 2009 |
Comparison of vildagliptin and pioglitazone in patients with type 2 diabetes inadequately controlled with metformin.
Topics: Adamantane; Adolescent; Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptid | 2009 |
Extended release metformin for metabolic control assistance during prolonged clozapine administration: a 14 week, double-blind, parallel group, placebo-controlled study.
Topics: Adult; Anthropometry; Antipsychotic Agents; Blood Glucose; Blood Pressure; Body Mass Index; Body Wei | 2009 |
Effects of bed-time insulin versus pioglitazone on abdominal fat accumulation, inflammation and gene expression in adipose tissue in patients with type 2 diabetes.
Topics: Adipose Tissue; Adolescent; Adult; Aged; Aged, 80 and over; Antigens, CD; Antigens, Differentiation, | 2009 |
Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; D | 2009 |
Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; D | 2009 |
Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; D | 2009 |
Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; D | 2009 |
Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: A randomized noninferiority trial.
Topics: Administration, Inhalation; Aged; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Drug Ther | 2009 |
Pubertal metformin therapy to reduce total, visceral, and hepatic adiposity.
Topics: Adiposity; Adolescent; Body Weight; Child; Comorbidity; Female; Follow-Up Studies; Humans; Hyperinsu | 2010 |
Effects of sitagliptin or metformin added to pioglitazone monotherapy in poorly controlled type 2 diabetes mellitus patients.
Topics: Adiponectin; Blood Glucose; Body Weight; C-Reactive Protein; Diabetes Mellitus, Type 2; Diet; Double | 2010 |
Effects of sitagliptin or metformin added to pioglitazone monotherapy in poorly controlled type 2 diabetes mellitus patients.
Topics: Adiponectin; Blood Glucose; Body Weight; C-Reactive Protein; Diabetes Mellitus, Type 2; Diet; Double | 2010 |
Effects of sitagliptin or metformin added to pioglitazone monotherapy in poorly controlled type 2 diabetes mellitus patients.
Topics: Adiponectin; Blood Glucose; Body Weight; C-Reactive Protein; Diabetes Mellitus, Type 2; Diet; Double | 2010 |
Effects of sitagliptin or metformin added to pioglitazone monotherapy in poorly controlled type 2 diabetes mellitus patients.
Topics: Adiponectin; Blood Glucose; Body Weight; C-Reactive Protein; Diabetes Mellitus, Type 2; Diet; Double | 2010 |
Baseline atherosclerosis parameter could assess the risk of bone loss during pioglitazone treatment in type 2 diabetes mellitus.
Topics: Aged; Atherosclerosis; Biomarkers; Blood Glucose; Body Weight; Bone Density; Collagen; Diabetes Mell | 2010 |
Exenatide versus glibenclamide in patients with diabetes.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Body Mass Index; Body Weight; C-Reactive | 2010 |
The effect of comprehensive lifestyle intervention or metformin on obesity in young women.
Topics: Adolescent; Adult; Behavior Therapy; Body Composition; Body Mass Index; Body Weight; Double-Blind Me | 2011 |
Effects of the peroxisome proliferator-activated receptor (PPAR)-gamma agonist pioglitazone on renal and hormonal responses to salt in diabetic and hypertensive individuals.
Topics: Analysis of Variance; Blood Pressure; Body Weight; Cross-Over Studies; Diabetes Mellitus, Type 2; Do | 2010 |
Metformin 2,500 mg/day in the treatment of obese women with polycystic ovary syndrome and its effect on weight, hormones, and lipid profile.
Topics: Adult; Body Weight; Female; Hormones; Humans; Hypoglycemic Agents; Lipids; Metformin; Obesity; Polyc | 2010 |
Metformin and placebo therapy both improve weight management and fasting insulin in obese insulin-resistant adolescents: a prospective, placebo-controlled, randomized study.
Topics: Adolescent; Body Mass Index; Body Weight; Child; Female; Humans; Hypoglycemic Agents; Insulin; Insul | 2010 |
Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study.
Topics: Adamantane; Adolescent; Adult; Aged; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Dr | 2010 |
Benefits of self-monitoring blood glucose in the management of new-onset Type 2 diabetes mellitus: the St Carlos Study, a prospective randomized clinic-based interventional study with parallel groups.
Topics: Blood Glucose Self-Monitoring; Blood Pressure; Body Mass Index; Body Weight; Diabetes Mellitus, Type | 2010 |
Pharmacological treatment of the pathogenetic defects in type 2 diabetes: the randomized multicenter South Danish Diabetes Study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Hum | 2011 |
Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial.
Topics: Aged; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administration Schedule; Dru | 2011 |
Effects of metformin on body weight and body composition in obese insulin-resistant children: a randomized clinical trial.
Topics: Body Composition; Body Weight; Child; Double-Blind Method; Female; Humans; Hypoglycemic Agents; Insu | 2011 |
The effects of metformin or orlistat on obese women with polycystic ovary syndrome: a prospective randomized open-label study.
Topics: Adult; Anti-Obesity Agents; Body Mass Index; Body Weight; Female; Humans; Hypoglycemic Agents; Lacto | 2011 |
Exenatide or glimepiride added to metformin on metabolic control and on insulin resistance in type 2 diabetic patients.
Topics: Biomarkers; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Exenatide; Femal | 2011 |
Effects of combined exenatide and pioglitazone therapy on hepatic fat content in type 2 diabetes.
Topics: Adiponectin; Adipose Tissue; Alanine Transaminase; Aspartate Aminotransferases; Biomarkers; Blood Gl | 2011 |
Effects of exenatide on measures of β-cell function after 3 years in metformin-treated patients with type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; Exenatide; Female; Gl | 2011 |
Exenatide decreases hepatic fibroblast growth factor 21 resistance in non-alcoholic fatty liver disease in a mouse model of obesity and in a randomised controlled trial.
Topics: Adult; Aged; Animals; Body Weight; Diabetes Mellitus, Type 2; Disease Models, Animal; Drug Therapy, | 2011 |
Effects of acarbose versus glibenclamide on glycemic excursion and oxidative stress in type 2 diabetic patients inadequately controlled by metformin: a 24-week, randomized, open-label, parallel-group comparison.
Topics: Acarbose; Adult; Aged; Biomarkers; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dinoprost; | 2011 |
Effects of acarbose versus glibenclamide on glycemic excursion and oxidative stress in type 2 diabetic patients inadequately controlled by metformin: a 24-week, randomized, open-label, parallel-group comparison.
Topics: Acarbose; Adult; Aged; Biomarkers; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dinoprost; | 2011 |
Effects of acarbose versus glibenclamide on glycemic excursion and oxidative stress in type 2 diabetic patients inadequately controlled by metformin: a 24-week, randomized, open-label, parallel-group comparison.
Topics: Acarbose; Adult; Aged; Biomarkers; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dinoprost; | 2011 |
Effects of acarbose versus glibenclamide on glycemic excursion and oxidative stress in type 2 diabetic patients inadequately controlled by metformin: a 24-week, randomized, open-label, parallel-group comparison.
Topics: Acarbose; Adult; Aged; Biomarkers; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dinoprost; | 2011 |
Appropriate insulin initiation dosage for insulin-naive type 2 diabetes outpatients receiving insulin monotherapy or in combination with metformin and/or pioglitazone.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Femal | 2010 |
Genetic predictors of weight loss and weight regain after intensive lifestyle modification, metformin treatment, or standard care in the Diabetes Prevention Program.
Topics: Alpha-Ketoglutarate-Dependent Dioxygenase FTO; Body Weight; Brain-Derived Neurotrophic Factor; Cell | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Topics: Adipose Tissue; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Fat Distribution; Body Mass I | 2012 |
Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study.
Topics: Adult; Antipsychotic Agents; Blood Glucose; Body Mass Index; Body Weight; Double-Blind Method; Femal | 2012 |
Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial.
Topics: Adolescent; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2 | 2012 |
Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial.
Topics: Adolescent; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2 | 2012 |
Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial.
Topics: Adolescent; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2 | 2012 |
Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial.
Topics: Adolescent; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2 | 2012 |
Glycemic control over 5 years in 4,900 people with type 2 diabetes: real-world diabetes therapy in a clinical trial cohort.
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemic Agents; In | 2012 |
Long-term effects of adding exenatide to a regimen of metformin and/or sulfonylurea in type 2 diabetes: an uncontrolled, open-label trial in Hungary.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; Female; | 2012 |
Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial.
Topics: Adult; Aged; Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Hypoglycem | 2012 |
Metformin for treatment of antipsychotic-induced amenorrhea and weight gain in women with first-episode schizophrenia: a double-blind, randomized, placebo-controlled study.
Topics: Adolescent; Adult; Amenorrhea; Antipsychotic Agents; Blood Glucose; Body Mass Index; Body Weight; Do | 2012 |
Comparing the efficacy and safety profile of sitagliptin versus glimepiride in patients of type 2 diabetes mellitus inadequately controlled with metformin alone.
Topics: Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Dose-Response Relationsh | 2012 |
Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Gl | 2012 |
Improved glycaemic control with vildagliptin added to insulin, with or without metformin, in patients with type 2 diabetes mellitus.
Topics: Adamantane; Adolescent; Adult; Aged; Aged, 80 and over; Asia; Australia; Blood Glucose; Body Weight; | 2013 |
Treatment with pioglitazone is associated with decreased preprandial ghrelin levels: a randomized clinical trial.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Ghrelin; Glucose Tolerance Tes | 2013 |
A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Argentina; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabete | 2013 |
A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Argentina; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabete | 2013 |
A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Argentina; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabete | 2013 |
A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Argentina; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabete | 2013 |
A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Argentina; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabete | 2013 |
A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Argentina; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabete | 2013 |
A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Argentina; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabete | 2013 |
A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Argentina; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabete | 2013 |
A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
Topics: Adult; Aged; Aged, 80 and over; Argentina; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabete | 2013 |
[The efficacy and safety of pioglitazone hydrochloride in combination with sulphonylureas and metfomin in the treatment of type 2 diabetes mellitus a 12-week randomized multi-centres placebo-controlled parallel study].
Topics: Blood Pressure; Body Weight; Cholesterol; Consumer Product Safety; Diabetes Mellitus, Type 2; Dose-R | 2002 |
Improved glycaemic control with metformin-glibenclamide combined tablet therapy (Glucovance) in Type 2 diabetic patients inadequately controlled on metformin.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Double-Blin | 2002 |
The effect of metformin on hirsutism in polycystic ovary syndrome.
Topics: Body Constitution; Body Height; Body Weight; Double-Blind Method; Female; Hair; Hirsutism; Humans; H | 2002 |
Rosiglitazone but not metformin enhances insulin- and exercise-stimulated skeletal muscle glucose uptake in patients with newly diagnosed type 2 diabetes.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Exercise; F | 2002 |
A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin.
Topics: Appetite Depressants; Blood Glucose; Blood Pressure; Body Weight; Cyclobutanes; Diabetes Mellitus; D | 2003 |
Differential effects of rosiglitazone and metformin on adipose tissue distribution and glucose uptake in type 2 diabetic subjects.
Topics: Adipose Tissue; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Fluorodeoxygluc | 2003 |
Effect on glycemic control of exenatide (synthetic exendin-4) additive to existing metformin and/or sulfonylurea treatment in patients with type 2 diabetes.
Topics: Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Ex | 2003 |
Efficacy of glyburide/metformin tablets compared with initial monotherapy in type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Combin | 2003 |
Efficacy, tolerability and safety of nateglinide in combination with metformin. Results from a study under general practice conditions.
Topics: Adult; Aged; Aged, 80 and over; Blood Glucose; Blood Pressure; Body Weight; Cyclohexanes; Diabetes M | 2003 |
Metformin therapy increases insulin-stimulated release of D-chiro-inositol-containing inositolphosphoglycan mediator in women with polycystic ovary syndrome.
Topics: Adolescent; Adult; Area Under Curve; Body Mass Index; Body Weight; Female; Glucose Tolerance Test; H | 2004 |
Effect of metformin treatment on multiple cardiovascular disease risk factors in patients with type 2 diabetes mellitus.
Topics: Aged; Blood Glucose; Blood Pressure; Body Weight; Cardiovascular Diseases; Cholesterol; Diabetes Mel | 2004 |
Nonobese women with polycystic ovary syndrome respond better than obese women to treatment with metformin.
Topics: Administration, Oral; Adult; Body Mass Index; Body Weight; Double-Blind Method; Female; Hormones; Hu | 2004 |
Effects of a combination of recombinant human growth hormone with metformin on glucose metabolism and body composition in patients with metabolic syndrome.
Topics: Aged; Arginine; Blood Glucose; Blood Pressure; Body Composition; Body Constitution; Body Weight; Dia | 2004 |
Metformin during pregnancy reduces insulin, insulin resistance, insulin secretion, weight, testosterone and development of gestational diabetes: prospective longitudinal assessment of women with polycystic ovary syndrome from preconception throughout preg
Topics: Adult; Body Weight; Cohort Studies; Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insu | 2004 |
Effect of pramlintide on weight in overweight and obese insulin-treated type 2 diabetes patients.
Topics: Aged; Amyloid; Body Mass Index; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Bl | 2004 |
Height, weight, and motor-social development during the first 18 months of life in 126 infants born to 109 mothers with polycystic ovary syndrome who conceived on and continued metformin through pregnancy.
Topics: Adult; Body Height; Body Weight; Child Development; Diabetes, Gestational; Female; Humans; Hypoglyce | 2004 |
Improved glycemic control without weight gain using triple therapy in type 2 diabetes.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Ethnicity; Female; | 2004 |
Effect of metformin vs. placebo treatment on serum fatty acids in non-diabetic obese insulin resistant individuals.
Topics: Adult; Anthropometry; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; | 2004 |
Orlistat is as beneficial as metformin in the treatment of polycystic ovarian syndrome.
Topics: Adult; Blood Pressure; Body Mass Index; Body Weight; Cholesterol; Enzyme Inhibitors; Female; Humans; | 2005 |
Homocysteine levels in women with polycystic ovary syndrome treated with metformin versus rosiglitazone: a randomized study.
Topics: Adult; Anovulation; Blood Glucose; Body Weight; Female; Folic Acid; Homocysteine; Humans; Hypoglycem | 2005 |
Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Gly | 2005 |
Comparison of effect of pioglitazone with metformin or sulfonylurea (monotherapy and combination therapy) on postload glycemia and composite insulin sensitivity index during an oral glucose tolerance test in patients with type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Femal | 2005 |
Administration of B-group vitamins reduces circulating homocysteine in polycystic ovarian syndrome patients treated with metformin: a randomized trial.
Topics: Adolescent; Adult; Blood Glucose; Body Weight; Dose-Response Relationship, Drug; Female; Folic Acid; | 2005 |
Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exena | 2005 |
Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exena | 2005 |
Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exena | 2005 |
Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exena | 2005 |
Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exena | 2005 |
Safety and tolerability of pioglitazone, metformin, and gliclazide in the treatment of type 2 diabetes.
Topics: Adult; Aged; Alanine Transaminase; Alkaline Phosphatase; Aspartate Aminotransferases; Blood Glucose; | 2005 |
Role of insulin secretion and sensitivity in the evolution of type 2 diabetes in the diabetes prevention program: effects of lifestyle intervention and metformin.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Female; Glucose Tolerance Tes | 2005 |
Role of insulin secretion and sensitivity in the evolution of type 2 diabetes in the diabetes prevention program: effects of lifestyle intervention and metformin.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Female; Glucose Tolerance Tes | 2005 |
Role of insulin secretion and sensitivity in the evolution of type 2 diabetes in the diabetes prevention program: effects of lifestyle intervention and metformin.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Female; Glucose Tolerance Tes | 2005 |
Role of insulin secretion and sensitivity in the evolution of type 2 diabetes in the diabetes prevention program: effects of lifestyle intervention and metformin.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Female; Glucose Tolerance Tes | 2005 |
The effects of rosiglitazone and metformin on oxidative stress and homocysteine levels in lean patients with polycystic ovary syndrome.
Topics: Adult; Androgens; Antioxidants; Blood Glucose; Body Mass Index; Body Weight; Female; Homeostasis; Ho | 2005 |
Biphasic insulin aspart 30 plus metformin: an effective combination in type 2 diabetes.
Topics: Biphasic Insulins; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedu | 2006 |
Comparative efficacy of glimepiride and/or metformin with insulin in type 2 diabetes.
Topics: Aged; Blood Glucose; Body Mass Index; Body Weight; Chemotherapy, Adjuvant; Diabetes Mellitus, Type 2 | 2006 |
Metformin-glibenclamide versus metformin plus rosiglitazone in patients with type 2 diabetes inadequately controlled on metformin monotherapy.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Combin | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasti | 2006 |
Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Cardiovascular Diseases; Diabet | 2006 |
Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Cardiovascular Diseases; Diabet | 2006 |
Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Cardiovascular Diseases; Diabet | 2006 |
Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes.
Topics: Adolescent; Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Cardiovascular Diseases; Diabet | 2006 |
Insulin sensitivity during oral glucose tolerance test and its relations to parameters of glucose metabolism and endothelial function in type 2 diabetic subjects under metformin and thiazolidinedione.
Topics: Blood Glucose; Body Weight; C-Peptide; Cell Adhesion Molecules; Chromans; Diabetes Mellitus, Type 2; | 2006 |
Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Com | 2006 |
Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride.
Topics: Aged; Biphasic Insulins; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relati | 2006 |
Changes in weight, papilledema, headache, visual field, and life status in response to diet and metformin in women with idiopathic intracranial hypertension with and without concurrent polycystic ovary syndrome or hyperinsulinemia.
Topics: Adolescent; Adult; Body Mass Index; Body Weight; Combined Modality Therapy; Diet, Reducing; Female; | 2006 |
Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin. Effect of body weight, gender, and race on systemic exposures of each drug.
Topics: Administration, Oral; Adult; Area Under Curve; Biological Availability; Black People; Body Weight; D | 2007 |
Effect of metformin on serum lipoprotein lipase mass levels and LDL particle size in type 2 diabetes mellitus patients.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated H | 2007 |
Targeting hyperglycaemia with either metformin or repaglinide in non-obese patients with type 2 diabetes: results from a randomized crossover trial.
Topics: Adiponectin; Biomarkers; Blood Glucose; Body Weight; C-Peptide; C-Reactive Protein; Carbamates; Cros | 2007 |
Comparison of two doses of metformin (2.5 and 1.5 g/day) for the treatment of polycystic ovary syndrome and their effect on body mass index and waist circumference.
Topics: Adult; Body Mass Index; Body Weight; Dose-Response Relationship, Drug; Drug Administration Schedule; | 2007 |
Metformin as an adjunctive treatment to control body weight and metabolic dysfunction during olanzapine administration: a multicentric, double-blind, placebo-controlled trial.
Topics: Adult; Antipsychotic Agents; Benzodiazepines; Bipolar Disorder; Blood Glucose; Body Mass Index; Body | 2007 |
Insulin sensitivity after metformin suspension in normal-weight women with polycystic ovary syndrome.
Topics: Adult; Area Under Curve; Body Mass Index; Body Weight; Female; Glucose Clamp Technique; Hormones; Hu | 2007 |
Metformin in normal-weight hirsute women with polycystic ovary syndrome with normal insulin sensitivity.
Topics: Adolescent; Adult; Blood Glucose; Body Weight; Female; Hirsutism; Hormones; Humans; Hypoglycemic Age | 2007 |
Prevention of gestational diabetes by metformin plus diet in patients with polycystic ovary syndrome.
Topics: Adult; Blood Glucose; Body Weight; Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insul | 2008 |
Efficacy of metformin in obese and non-obese women with polycystic ovary syndrome: a randomized, double-blinded, placebo-controlled cross-over trial.
Topics: Adolescent; Adult; Body Weight; Cross-Over Studies; Double-Blind Method; Female; Humans; Insulin; Me | 2007 |
Metformin reduces thyrotropin levels in obese, diabetic women with primary hypothyroidism on thyroxine replacement therapy.
Topics: Aged; Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agen | 2007 |
Efficacy and tolerability of vildagliptin vs. pioglitazone when added to metformin: a 24-week, randomized, double-blind study.
Topics: Adamantane; Adolescent; Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-B | 2008 |
Metformin for metabolic dysregulation in schizophrenic patients treated with olanzapine.
Topics: Adolescent; Adult; Antipsychotic Agents; Benzodiazepines; Blood Glucose; Body Weight; Female; Glucos | 2008 |
Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial.
Topics: Adult; Blood Glucose; Body Weight; Cross-Over Studies; Diabetes Mellitus, Type 2; Double-Blind Metho | 2007 |
Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes.
Topics: Adult; Aged; Area Under Curve; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fe | 2008 |
Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.
Topics: Analysis of Variance; Biomarkers; Blood Glucose; Body Weight; Cholesterol, LDL; Diabetes Mellitus, T | 2008 |
Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.
Topics: Analysis of Variance; Biomarkers; Blood Glucose; Body Weight; Cholesterol, LDL; Diabetes Mellitus, T | 2008 |
Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.
Topics: Analysis of Variance; Biomarkers; Blood Glucose; Body Weight; Cholesterol, LDL; Diabetes Mellitus, T | 2008 |
Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.
Topics: Analysis of Variance; Biomarkers; Blood Glucose; Body Weight; Cholesterol, LDL; Diabetes Mellitus, T | 2008 |
Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.
Topics: Analysis of Variance; Biomarkers; Blood Glucose; Body Weight; Cholesterol, LDL; Diabetes Mellitus, T | 2008 |
Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.
Topics: Analysis of Variance; Biomarkers; Blood Glucose; Body Weight; Cholesterol, LDL; Diabetes Mellitus, T | 2008 |
Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.
Topics: Analysis of Variance; Biomarkers; Blood Glucose; Body Weight; Cholesterol, LDL; Diabetes Mellitus, T | 2008 |
Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.
Topics: Analysis of Variance; Biomarkers; Blood Glucose; Body Weight; Cholesterol, LDL; Diabetes Mellitus, T | 2008 |
Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.
Topics: Analysis of Variance; Biomarkers; Blood Glucose; Body Weight; Cholesterol, LDL; Diabetes Mellitus, T | 2008 |
Metformin, but not pioglitazone, decreases postchallenge plasma ghrelin levels in type 2 diabetic patients: a possible role in weight stability?
Topics: Area Under Curve; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Female; Gh | 2008 |
The metabolic effects of once daily extended-release metformin in patients with type 2 diabetes: a multicentre study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Delayed-Action Preparations; Diabetes Mellitus, Type 2; Fem | 2008 |
Impact of metformin versus repaglinide on non-glycaemic cardiovascular risk markers related to inflammation and endothelial dysfunction in non-obese patients with type 2 diabetes.
Topics: Aged; Blood Glucose; Body Weight; Carbamates; Cross-Over Studies; Diabetes Mellitus, Type 2; Diabeti | 2008 |
Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.
Topics: Adiponectin; Adult; Body Weight; Drug Therapy, Combination; Exenatide; Female; Humans; Lipids; Menst | 2008 |
Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.
Topics: Adiponectin; Adult; Body Weight; Drug Therapy, Combination; Exenatide; Female; Humans; Lipids; Menst | 2008 |
Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.
Topics: Adiponectin; Adult; Body Weight; Drug Therapy, Combination; Exenatide; Female; Humans; Lipids; Menst | 2008 |
Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.
Topics: Adiponectin; Adult; Body Weight; Drug Therapy, Combination; Exenatide; Female; Humans; Lipids; Menst | 2008 |
Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.
Topics: Adiponectin; Adult; Body Weight; Drug Therapy, Combination; Exenatide; Female; Humans; Lipids; Menst | 2008 |
Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.
Topics: Adiponectin; Adult; Body Weight; Drug Therapy, Combination; Exenatide; Female; Humans; Lipids; Menst | 2008 |
Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.
Topics: Adiponectin; Adult; Body Weight; Drug Therapy, Combination; Exenatide; Female; Humans; Lipids; Menst | 2008 |
Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.
Topics: Adiponectin; Adult; Body Weight; Drug Therapy, Combination; Exenatide; Female; Humans; Lipids; Menst | 2008 |
Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.
Topics: Adiponectin; Adult; Body Weight; Drug Therapy, Combination; Exenatide; Female; Humans; Lipids; Menst | 2008 |
Ciclazindol: an oral agent with weight reducing properties and hypoglycaemic activity.
Topics: Adult; Aged; Appetite Depressants; Body Weight; Diabetes Mellitus; Female; Glucose Tolerance Test; H | 1983 |
Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind | 1995 |
Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind | 1995 |
Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind | 1995 |
Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind | 1995 |
Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind | 1995 |
Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind | 1995 |
Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind | 1995 |
Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind | 1995 |
Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus. The Multicenter Metformin Study Group.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind | 1995 |
Therapeutic comparison of metformin and sulfonylurea, alone and in various combinations. A double-blind controlled study.
Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; Drug | 1994 |
United Kingdom Prospective Diabetes Study (UKPDS). 13: Relative efficacy of randomly allocated diet, sulphonylurea, insulin, or metformin in patients with newly diagnosed non-insulin dependent diabetes followed for three years.
Topics: Adult; Aged; Blood Glucose; Body Weight; Chlorpropamide; Diabetes Mellitus; Diabetes Mellitus, Type | 1995 |
Metformin and metoprolol CR treatment in non-obese men.
Topics: Analysis of Variance; Anthropometry; Blood Pressure; Body Weight; Delayed-Action Preparations; Doubl | 1994 |
Comparison between acarbose, metformin, and insulin treatment in type 2 diabetic patients with secondary failure to sulfonylurea treatment.
Topics: Acarbose; Aged; Blood Glucose; Blood Pressure; Body Mass Index; Body Weight; Cholesterol; Cholestero | 1995 |
Improvement of insulin sensitivity by metformin treatment does not lower blood pressure of nonobese insulin-resistant hypertensive patients with normal glucose tolerance.
Topics: Adult; Aged; Alanine; Aldosterone; Blood Glucose; Blood Pressure; Body Weight; Cross-Over Studies; D | 1996 |
The effects of high- and medium-dose metformin therapy on cardiovascular risk factors in patients with type II diabetes.
Topics: Analysis of Variance; Blood Glucose; Blood Pressure; Body Weight; Cardiovascular Diseases; Cholester | 1996 |
Metformin improves blood lipid pattern in nondiabetic patients with coronary heart disease.
Topics: Blood Glucose; Body Weight; Combined Modality Therapy; Coronary Disease; Diet; Humans; Hyperlipidemi | 1996 |
Effects of metformin on the pathways of glucose utilization after oral glucose in non-insulin-dependent diabetes mellitus patients.
Topics: Administration, Oral; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Fasting; Glucose; Gluco | 1997 |
The effects of metformin on glycemic control and serum lipids in insulin-treated NIDDM patients with suboptimal metabolic control.
Topics: Aged; Blood Glucose; Blood Pressure; Body Weight; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; C | 1998 |
Irreversibility of the defect in glycogen synthase activity in skeletal muscle from obese patients with NIDDM treated with diet and metformin.
Topics: Adult; Blood Glucose; Body Weight; Calorimetry, Indirect; Diabetes Mellitus; Diabetes Mellitus, Type | 1998 |
Effects of metformin in patients with poorly controlled, insulin-treated type 2 diabetes mellitus. A randomized, double-blind, placebo-controlled trial.
Topics: Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, | 1999 |
A comparison of preconstituted, fixed combinations of low-dose glyburide plus metformin versus high-dose glyburide alone in the treatment of type 2 diabetic patients.
Topics: Blood Glucose; Body Weight; C-Peptide; Cross-Over Studies; Diabetes Mellitus, Type 2; Double-Blind M | 1999 |
A comparison of troglitazone and metformin on insulin requirements in euglycemic intensively insulin-treated type 2 diabetic patients.
Topics: Blood Glucose; Body Weight; C-Peptide; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Chromans; Ci | 1999 |
Intensive insulin therapy combined with metformin in obese type 2 diabetic patients.
Topics: Body Mass Index; Body Weight; C-Peptide; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; | 2000 |
The effects of metformin on body mass index and glucose tolerance in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes.
Topics: Adolescent; Blood Glucose; Body Mass Index; Body Weight; Child; Comorbidity; Diabetes Mellitus; Diab | 2001 |
Metabolic effects of metformin in patients with impaired glucose tolerance.
Topics: Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Energy Metabolism; Fatty Acid | 2001 |
Vascular effects of glibenclamide vs. glimepiride and metformin in Type 2 diabetic patients.
Topics: Acetylcholine; Adult; Aged; Blood Flow Velocity; Blood Pressure; Body Mass Index; Body Weight; C-Pep | 2002 |
Evaluation of the safety and efficacy of sibutramine, orlistat and metformin in the treatment of obesity.
Topics: Adult; Anti-Obesity Agents; Appetite Depressants; Blood Glucose; Body Mass Index; Body Weight; Cyclo | 2002 |
Long-term glycaemic improvement after addition of metformin to insulin in insulin-treated obese type 2 diabetes patients.
Topics: Blood Glucose; Blood Pressure; Body Mass Index; Body Weight; Cholesterol; Diabetes Mellitus; Diabete | 2001 |
Short-term treatment with metformin decreases serum leptin concentration without affecting body weight and body fat content in normal-weight healthy men.
Topics: Adipose Tissue; Adult; Blood Pressure; Body Weight; C-Peptide; Diabetes Mellitus; Glucagon; Humans; | 2002 |
Nateglinide improves glycaemic control when added to metformin monotherapy: results of a randomized trial with type 2 diabetes patients.
Topics: Aged; Blood Glucose; Body Mass Index; Body Weight; Cholesterol; Cyclohexanes; Diabetes Mellitus, Typ | 2002 |
Simultaneous glyburide/metformin therapy is superior to component monotherapy as an initial pharmacological treatment for type 2 diabetes.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Fasting; Female; G | 2002 |
Effect of orlistat in overweight and obese patients with type 2 diabetes treated with metformin.
Topics: Adult; Aged; Anti-Obesity Agents; Blood Glucose; Blood Pressure; Body Weight; Cholesterol; Diabetes | 2002 |
Glipizide in the treatment of maturity-onset diabetes: a multi-centre, out-patient study.
Topics: Adult; Aged; Blood Glucose; Body Weight; Clinical Trials as Topic; Diabetes Mellitus; Female; Glipiz | 1978 |
Comparison of metformin and chlorpropamide in non-obese, maturity-onset diabetics uncontrolled by diet.
Topics: Administration, Oral; Adult; Age Factors; Aged; Body Weight; Chlorpropamide; Diabetes Mellitus; Diet | 1977 |
[Therapy of diabetes mellitus using metformin. Clinical study on 60 patients].
Topics: Body Weight; Clinical Trials as Topic; Delayed-Action Preparations; Diabetes Mellitus; Drug Therapy, | 1975 |
[Antidiabetic efficacy of benfluorex. Clinical data].
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Fenfluramine; Humans; Hypolipidemic A | 1992 |
Comparison of combined therapies in treatment of secondary failure to glyburide.
Topics: Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus; Diabetes Mellitus, Type 2; Drug Administra | 1992 |
Prospective comparative study in NIDDM patients of metformin and glibenclamide with special reference to lipid profiles.
Topics: Administration, Oral; Adult; Aged; Blood Glucose; Body Weight; C-Peptide; Cholesterol; Diabetes Mell | 1991 |
Comparative three-month study of the efficacies of metformin and gliclazide in the treatment of NIDD.
Topics: Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Fasting; Female; Gliclazide; Hum | 1991 |
Double-blind evaluation of efficacy and tolerability of metformin in NIDDM.
Topics: Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Double-Blind Method; Femal | 1991 |
Comparison of tolbutamide and metformin in elderly diabetic patients.
Topics: Aged; Aged, 80 and over; Blood Glucose; Body Weight; Clinical Trials as Topic; Diabetes Mellitus, Ty | 1990 |
Different effects of insulin and oral antidiabetic agents on glucose and energy metabolism in type 2 (non-insulin-dependent) diabetes mellitus.
Topics: Blood Glucose; Blood Glucose Self-Monitoring; Body Weight; Cholesterol; Diabetes Mellitus, Type 2; D | 1989 |
Comparison of chlorpropamide and metformin treatment on weight and blood-glucose response of uncontrolled obese diabetics.
Topics: Adult; Aged; Blood Glucose; Body Weight; Chlorpropamide; Diabetes Mellitus; Diet Therapy; Female; Hu | 1968 |
Comparison of fenfluramine and metformin in treatment of obesity.
Topics: Adult; Appetite Depressants; Body Weight; Clinical Trials as Topic; Female; Fenfluramine; Fluorine; | 1970 |
Weight-reducing effect of diguanides in obese non-diabetic women.
Topics: Adult; Appetite; Bicarbonates; Body Weight; Clinical Trials as Topic; Female; Glucose Tolerance Test | 1969 |
[Effect of metformin on glucose utilization and body weight].
Topics: Biguanides; Blood Glucose; Body Weight; Glucose; Glucose Tolerance Test; Humans; Injections, Intrave | 1970 |
323 other studies available for metformin and Body Weight
| Article | Year |
|---|---|
Antihyperglycemic activity of phenolics from Pterocarpus marsupium.
Topics: Animals; Benzofurans; Blood Glucose; Body Weight; Cresols; Diabetes Mellitus, Experimental; Female; | 1997 |
Maprouneacin, a new daphnane diterpenoid with potent antihyperglycemic activity from Maprounea africana.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Diterpenes; Feeding Behavior; Hypogl | 1999 |
Antihyperglycemic sesquiterpenes from Psacalium decompositum.
Topics: Animals; Asteraceae; Blood Glucose; Body Weight; Chromatography, High Pressure Liquid; Diabetes Mell | 1999 |
Synthesis of novel triterpenoid (lupeol) derivatives and their in vivo antihyperglycemic and antidyslipidemic activity.
Topics: Animals; Anti-Inflammatory Agents; Body Weight; Chemistry, Pharmaceutical; Cricetinae; Diabetes Mell | 2009 |
Synthesis and biological evaluation of 5-benzylidenepyrimidine-2,4,6(1H,3H,5H)-trione derivatives for the treatment of obesity-related nonalcoholic fatty liver disease.
Topics: 3T3-L1 Cells; Adipocytes; Adiponectin; Alanine Transaminase; Animals; Barbiturates; Body Weight; Cho | 2012 |
Discovery of tetrahydrocarbazoles with potent hypoglycemic and hypolipemic activities.
Topics: Blood Glucose; Body Weight; Carbazoles; Dose-Response Relationship, Drug; Drug Discovery; Hep G2 Cel | 2018 |
Toward a treatment of diabesity: In vitro and in vivo evaluation of uncharged bromophenol derivatives as a new series of PTP1B inhibitors.
Topics: Animals; Body Weight; Cell Line; Diabetes Mellitus, Type 2; Drug Evaluation, Preclinical; Enzyme Inh | 2019 |
Metformin and exenatide upregulate hepatocyte nuclear factor-4α, sex hormone binding globulin levels and improve hepatic triglyceride deposition in polycystic ovary syndrome with insulin resistance rats.
Topics: Animals; Body Weight; Estrous Cycle; Exenatide; Female; Glucose Tolerance Test; Hepatocyte Nuclear F | 2021 |
Coadministration of sitagliptin or metformin has no major impact on the adverse metabolic outcomes induced by dexamethasone treatment in rats.
Topics: Animals; Blood Glucose; Body Weight; Dexamethasone; Diabetes Mellitus, Experimental; Feeding Behavio | 2021 |
Maternal Metformin Treatment during Gestation and Lactation Improves Skeletal Muscle Development in Offspring of Rat Dams Fed High-Fat Diet.
Topics: Animals; Biomarkers; Body Weight; Diet, High-Fat; Female; Gene Expression Regulation; Gestational Ag | 2021 |
Morphological and functional characterization of diabetic cardiomyopathy in db/db mice following exercise, metformin alone, or combination treatments.
Topics: Animals; Blood Pressure; Body Weight; Combined Modality Therapy; Diabetes Mellitus, Type 2; Diabetic | 2021 |
Metformin treatment of juvenile mice alters aging-related developmental and metabolic phenotypes.
Topics: Adiponectin; Age Factors; Aging; Animals; Body Weight; Feeding Behavior; Glucose Tolerance Test; Gro | 2022 |
Comparison of Beinaglutide Versus Metformin for Weight Loss in Overweight and Obese Non-diabetic Patients.
Topics: Body Weight; Diabetes Mellitus, Type 2; Glucagon-Like Peptide 1; Humans; Hypoglycemic Agents; Metfor | 2022 |
Dapagliflozin, metformin, monotherapy or both in patients with metabolic syndrome.
Topics: Adult; Benzhydryl Compounds; Body Weight; C-Reactive Protein; Cholesterol, HDL; Diabetes Mellitus, T | 2021 |
The Effects of Separate and Combined Treatment of Male Rats with Type 2 Diabetes with Metformin and Orthosteric and Allosteric Agonists of Luteinizing Hormone Receptor on Steroidogenesis and Spermatogenesis.
Topics: Adenylate Kinase; Allosteric Regulation; Animals; Area Under Curve; Blood Glucose; Body Weight; Diab | 2021 |
Beneficial effects of metformin supplementation in hypothalamic paraventricular nucleus and arcuate nucleus of type 2 diabetic rats.
Topics: Animals; Arcuate Nucleus of Hypothalamus; Astrocytes; Blood Glucose; Body Weight; Diabetes Mellitus, | 2022 |
Efficacy of tirzepatide 5, 10 and 15 mg versus semaglutide 2 mg in patients with type 2 diabetes: An adjusted indirect treatment comparison.
Topics: Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Gastric Inhibitory Polypeptide; Glucago | 2022 |
Predictors for successful weight reduction during treatment with Dapagliflozin among patients with type 2 diabetes mellitus in primary care.
Topics: Benzhydryl Compounds; Body Weight; Diabetes Mellitus, Type 2; Female; Glucosides; Humans; Male; Metf | 2022 |
Metformin, clomiphene citrate and flutamide effects on oocyte ultrastructure status and quality in PCOS mouse model.
Topics: Animals; Body Weight; Clomiphene; Female; Fertility Agents, Female; Flutamide; Humans; Infertility, | 2022 |
Linagliptin in Combination With Metformin Ameliorates Diabetic Osteoporosis Through Modulating BMP-2 and Sclerostin in the High-Fat Diet Fed C57BL/6 Mice.
Topics: Animals; Biomarkers; Body Weight; Calcium; Cytokines; Diabetes Mellitus, Experimental; Diet, High-Fa | 2022 |
Effect of Dapagliflozin in Combination with Lobeglitazone and Metformin in Korean Patients with Type 2 Diabetes in Real-World Clinical Practice.
Topics: Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Double-Blind Method; Dr | 2022 |
The consumption of sea buckthorn (Hippophae rhamnoides L.) effectively alleviates type 2 diabetes symptoms in spontaneous diabetic rats.
Topics: Animals; Antioxidants; Body Weight; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 2; Frui | 2022 |
A Health Care Professional Delivered Low Carbohydrate Diet Program Reduces Body Weight, Haemoglobin A1c, Diabetes Medication Use and Cardiovascular Risk Markers-A Single-Arm Intervention Analysis.
Topics: Adult; Body Weight; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diet, Car | 2022 |
Combining Dietary Intervention with Metformin Treatment Enhances Non-Alcoholic Steatohepatitis Remission in Mice Fed a High-Fat High-Sucrose Diet.
Topics: Animals; Body Weight; Diet, High-Fat; Insulin Resistance; Liver; Male; Metformin; Mice; Mice, Inbred | 2022 |
Metformin improves polycystic ovary syndrome in mice by inhibiting ovarian ferroptosis.
Topics: AMP-Activated Protein Kinases; Animals; Body Weight; Female; Ferroptosis; Humans; Insulin Resistance | 2023 |
Therapeutic Potential of Metformin-preconditioned Mesenchymal Stem Cells for Pancreatic Regeneration.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Insulin; Mesenchymal Stem Cell | 2023 |
Efficacy and safety of once-weekly efpeglenatide in people with suboptimally controlled type 2 diabetes: The AMPLITUDE-D, AMPLITUDE-L and AMPLITUDE-S randomized controlled trials.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Glucagon-Like Peptide 1; Glucagon-Like Peptid | 2023 |
Metformin triggers a kidney GDF15-dependent area postrema axis to regulate food intake and body weight.
Topics: Animals; Area Postrema; Body Weight; Diabetes Mellitus, Type 2; Eating; Growth Differentiation Facto | 2023 |
Vitamin D3 alleviates lung fibrosis of type 2 diabetic rats via SIRT3 mediated suppression of pyroptosis.
Topics: Animals; Apoptosis; Blood Glucose; Body Weight; Cholecalciferol; Diabetes Mellitus, Experimental; Di | 2023 |
Dalbergiella welwitschia (Baker) Baker f. alkaloid-rich extracts attenuate liver damage in streptozotocin-induced diabetic rats.
Topics: Alkaloids; Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Hypoglycemic Agents | 2023 |
Metformin improves vascular and metabolic insulin action in insulin-resistant muscle.
Topics: Animals; Blood Flow Velocity; Blood Glucose; Body Weight; Diet, High-Fat; Femoral Artery; Glucose; G | 2019 |
In uncontrolled type 2 diabetes, adjunctive semaglutide reduced HbA1c and body weight vs sitagliptin.
Topics: Adult; Body Weight; Diabetes Mellitus, Type 2; Glucagon-Like Peptides; Glycated Hemoglobin; Humans; | 2019 |
Effect of high-fat diet-induced obesity on thyroid gland structure in female rats and the possible ameliorating effect of metformin therapy.
Topics: Animals; Body Weight; Diet, High-Fat; Female; Hormones; Lipids; Metformin; Obesity; Rats; Thyroid Gl | 2020 |
Effects of berberine and metformin on intestinal inflammation and gut microbiome composition in db/db mice.
Topics: Animals; Berberine; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Diabetes Mellitus, | 2019 |
Letter to the Editor: Intrahepatic Lipid Content After Insulin Glargine Addition to Metformin in Type II Diabetes Mellitus With Nonalcoholic Fatty Liver Disease.
Topics: Body Weight; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Insulin Glargine; Lipids; Lirag | 2020 |
Reply.
Topics: Body Weight; Diabetes Mellitus, Type 2; Humans; Insulin Glargine; Lipids; Liraglutide; Metformin; No | 2020 |
Intensification of medical management in type 2 diabetes: A real-world look at primary care practice.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Body Weight; Choice Behavior; Diabetes Mellitus, Type 2; | 2020 |
Effect of Metformin on a Preeclampsia-Like Mouse Model Induced by High-Fat Diet.
Topics: Animals; Blood Pressure; Body Weight; Diet, High-Fat; Disease Models, Animal; Female; Matrix Metallo | 2019 |
Berberine attenuated olanzapine-induced metabolic alterations in mice: Targeting transient receptor potential vanilloid type 1 and 3 channels.
Topics: Animals; Antipsychotic Agents; Berberine; Body Temperature; Body Weight; Cytokines; Drinking; Female | 2020 |
Combined treatments with metformin and phosphodiesterase inhibitors alleviate nonalcoholic fatty liver disease in high-fat diet fed rats: a comparative study.
Topics: Alanine Transaminase; Animals; Aspartate Aminotransferases; Blood Glucose; Body Composition; Body We | 2020 |
Comparative effects of glibenclamide, metformin and insulin on fetal pancreatic histology and maternal blood glucose in pregnant streptozotocin-induced diabetic rats.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Diabetes, Gestational; Female; | 2019 |
Exenatide ameliorates experimental non-alcoholic fatty liver in rats via suppression of toll-like receptor 4/NFκB signaling: Comparison to metformin.
Topics: Animals; Body Weight; Diet, High-Fat; Disease Progression; Dose-Response Relationship, Drug; Exenati | 2020 |
Effects of metformin on blood glucose levels and bodyweight mediated through intestinal effects.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Intestinal Absor | 2020 |
Metabolic benefits of annatto-extracted tocotrienol on glucose homeostasis, inflammation, and gut microbiome.
Topics: Adipokines; Adipose Tissue, White; Animals; Bacteria; Bixaceae; Blood Glucose; Body Weight; Caroteno | 2020 |
Combined use of Diane-35 and metformin improves the ovulation in the PCOS rat model possibly via regulating glycolysis pathway.
Topics: Androgen Antagonists; Animals; Apoptosis; Body Weight; Cyproterone Acetate; Disease Models, Animal; | 2020 |
Combining a High Dose of Metformin With the SIRT1 Activator, SRT1720, Reduces Life Span in Aged Mice Fed a High-Fat Diet.
Topics: Animals; Body Composition; Body Weight; Diet, High-Fat; Heterocyclic Compounds, 4 or More Rings; Lon | 2020 |
Glycemic Efficacy and Metabolic Consequences of an Empagliflozin Add-on versus Conventional Dose-Increasing Strategy in Patients with Type 2 Diabetes Inadequately Controlled by Metformin and Sulfonylurea.
Topics: Adult; Aged; Benzhydryl Compounds; Biomarkers; Blood Glucose; Blood Pressure; Body Mass Index; Body | 2020 |
Metformin-induced increases in GDF15 are important for suppressing appetite and promoting weight loss.
Topics: Animals; Appetite Depressants; Body Weight; Diabetes Mellitus, Type 2; Diet, High-Fat; Eating; Gluco | 2019 |
Peanut skin extract ameliorates the symptoms of type 2 diabetes mellitus in mice by alleviating inflammation and maintaining gut microbiota homeostasis.
Topics: Animals; Anti-Inflammatory Agents; Arachis; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; E | 2020 |
Metformin effectively restores the HPA axis function in diet-induced obese rats.
Topics: Animals; Body Weight; Corticosterone; Diet, High-Fat; Hypothalamo-Hypophyseal System; Male; Metformi | 2021 |
Early metformin treatment improves pancreatic function and prevents metabolic dysfunction in early overfeeding male rats at adulthood.
Topics: Adipose Tissue, White; Animals; Animals, Newborn; Blood Glucose; Body Composition; Body Weight; Fema | 2020 |
Coadministration of metformin prevents olanzapine-induced metabolic dysfunction and regulates the gut-liver axis in rats.
Topics: Adjuvants, Pharmaceutic; Animals; Bacteroides; Blood Glucose; Body Weight; Dose-Response Relationshi | 2021 |
Metformin alleviates allergic airway inflammation and increases Treg cells in obese asthma.
Topics: Animals; Anti-Inflammatory Agents; Asthma; Body Weight; Bronchoalveolar Lavage Fluid; CD4 Lymphocyte | 2021 |
Effects of total flavonoids from Eucommia ulmoides Oliv. leaves on polycystic ovary syndrome with insulin resistance model rats induced by letrozole combined with a high-fat diet.
Topics: Animals; Body Weight; Diet, High-Fat; Disease Models, Animal; Eucommiaceae; Female; Flavonoids; Gona | 2021 |
Comparative evaluation of metformin and liraglutide cardioprotective effect in rats with impaired glucose tolerance.
Topics: Animals; Biomarkers; Blood Glucose; Body Weight; Cardiotonic Agents; Diabetes Mellitus, Experimental | 2021 |
Metformin prevents stroke damage in non-diabetic female mice with chronic kidney disease.
Topics: Adenylate Kinase; Animals; Apoptosis; Body Weight; Brain Infarction; Enzyme Activation; Female; Gene | 2021 |
Associations between second-line glucose-lowering combination therapies with metformin and HbA1c, body weight, quality of life, hypoglycaemic events and glucose-lowering treatment intensification: The DISCOVER study.
Topics: Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Combinatio | 2021 |
DBPR108, a novel dipeptidyl peptidase-4 inhibitor with antihyperglycemic activity.
Topics: Administration, Oral; Animals; Area Under Curve; Body Weight; Butanes; Diabetes Mellitus, Experiment | 2021 |
Metabolic benefits of novel histamine H
Topics: Adipose Tissue; Animals; Body Weight; C-Peptide; Carrier Proteins; Cholesterol; Energy Intake; Feedi | 2021 |
Interaction of clozapine with metformin in a schizophrenia rat model.
Topics: Animals; Behavior, Animal; Body Weight; Clozapine; Disease Models, Animal; Drug Interactions; Feedin | 2021 |
Metformin and leucine increase satellite cells and collagen remodeling during disuse and recovery in aged muscle.
Topics: Aging; AMP-Activated Protein Kinases; Animals; Body Weight; Collagen; Fibrosis; Hindlimb Suspension; | 2021 |
Impact of health policy and practice on finding the best fit for patients with type 2 diabetes after metformin failure: Croatian pilot study.
Topics: Administration, Oral; Aged; Biomarkers; Blood Glucose; Body Mass Index; Body Weight; Clinical Decisi | 2017 |
Metformin ameliorates hepatic steatosis and improves the induction of autophagy in HFD‑induced obese mice.
Topics: Adipose Tissue; AMP-Activated Protein Kinases; Animals; Autophagy; Body Weight; Diet, High-Fat; Dise | 2017 |
Diabetes-related weight change in a Canadian First Nation cohort.
Topics: Anthropometry; Body Weight; Cohort Studies; Diabetes Complications; Diabetes Mellitus, Type 2; Femal | 2017 |
Effect of Dapagliflozin on Glycemic Control, Weight, and Blood Pressure in Patients with Type 2 Diabetes Attending a Specialist Endocrinology Practice in Canada: A Retrospective Cohort Analysis.
Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Canada; Diabetes Mellitus, T | 2017 |
Involvement of insulin resistance in D-galactose-induced age-related dementia in rats: Protective role of metformin and saxagliptin.
Topics: Adamantane; Aging; Animals; Biomarkers; Body Weight; Brain; Dementia; Dipeptides; Galactose; Glycate | 2017 |
In utero and lactational exposure to metformin induces reproductive alterations in male rat offspring.
Topics: Animals; Body Weight; Female; Fertility; Genitalia, Male; Hypoglycemic Agents; Lactation; Male; Mate | 2017 |
In vivo therapeutic effect of combination treatment with metformin and Scutellaria baicalensis on maintaining bile acid homeostasis.
Topics: Algorithms; Animals; Bile Acids and Salts; Blood Glucose; Blotting, Western; Body Weight; Cholestero | 2017 |
Cohort profile for the MASTERMIND study: using the Clinical Practice Research Datalink (CPRD) to investigate stratification of response to treatment in patients with type 2 diabetes.
Topics: Adult; Aged; Body Mass Index; Body Weight; Databases as Topic; Diabetes Mellitus, Type 2; Disease Pr | 2017 |
Modulation of the gut microbiota by metformin improves metabolic profiles in aged obese mice.
Topics: Age Factors; Animals; Bacteria; Blood Glucose; Body Weight; Diet, High-Fat; Disease Models, Animal; | 2018 |
The effects of metformin in type 1 diabetes mellitus.
Topics: Adult; Biomarkers; Blood Glucose; Body Weight; C-Peptide; Case-Control Studies; Diabetes Mellitus, T | 2018 |
Comparison of costs and outcomes of dapagliflozin with other glucose-lowering therapy classes added to metformin using a short-term cost-effectiveness model in the US setting.
Topics: Benzhydryl Compounds; Blood Pressure; Body Weight; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; | 2018 |
IGF-1R and Leptin Expression Profile and the Effects of Metformin Treatment on Metabolic and Endocrine Parameters in PCOS Mice.
Topics: Animals; Blood Glucose; Body Weight; Female; Gene Expression Regulation; Humans; Hypoglycemic Agents | 2017 |
New insights on the modulatory roles of metformin or alpha-lipoic acid versus their combination in dextran sulfate sodium-induced chronic colitis in rats.
Topics: Animals; Antioxidants; Body Weight; Colitis; Colon; Dextran Sulfate; Disease Models, Animal; Male; M | 2018 |
Short-term combined treatment with exenatide and metformin is superior to glimepiride combined metformin in improvement of serum testosterone levels in type 2 diabetic patients with obesity.
Topics: Adult; Anti-Obesity Agents; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Com | 2018 |
Metformin alleviates bleomycin-induced pulmonary fibrosis in rats: Pharmacological effects and molecular mechanisms.
Topics: Animals; Biomarkers; Bleomycin; Body Weight; Bronchoalveolar Lavage Fluid; Cytokines; Disease Models | 2018 |
Intrauterine exposure to metformin: Evaluation of endothelial and perivascular adipose tissue function in abdominal aorta of adult offspring.
Topics: Adipose Tissue; Animals; Aorta, Abdominal; Body Weight; Dose-Response Relationship, Drug; Endothelia | 2018 |
Efficacy and safety of replacing sitagliptin with canagliflozin in real-world patients with type 2 diabetes uncontrolled with sitagliptin combined with metformin and/or gliclazide: The SITA-CANA Switch Study.
Topics: Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; Female; | 2018 |
Aerobic exercise, but not metformin, prevents reduction of muscular performance by AMPk activation in mice on doxorubicin chemotherapy.
Topics: Adipose Tissue; AMP-Activated Protein Kinases; Animals; Autophagy; Body Weight; Doxorubicin; Enzyme | 2018 |
Changes in HbA1c and weight, and treatment persistence, over the 18 months following initiation of second-line therapy in patients with type 2 diabetes: results from the United Kingdom Clinical Practice Research Datalink.
Topics: Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Ma | 2018 |
Synergistic action of ursolic acid and metformin in experimental model of insulin resistance and related behavioral alterations.
Topics: Acetylcholinesterase; Adiponectin; Animals; Behavior, Animal; Blood Pressure; Body Weight; Brain; Co | 2018 |
Sitagliptin attenuates myocardial apoptosis via activating LKB-1/AMPK/Akt pathway and suppressing the activity of GSK-3β and p38α/MAPK in a rat model of diabetic cardiomyopathy.
Topics: AMP-Activated Protein Kinase Kinases; AMP-Activated Protein Kinases; Animals; Apoptosis; Biomarkers; | 2018 |
Insulin Sensitizers Modulate GnRH Receptor Expression in PCOS Rats.
Topics: Animals; Body Weight; Carboxymethylcellulose Sodium; Diet, High-Fat; Female; Glucose Tolerance Test; | 2018 |
Antidiabetic Activity of Afobazole in Wistar Rats.
Topics: Animals; Anti-Anxiety Agents; Benzimidazoles; Blood Glucose; Body Weight; Diabetes Mellitus, Experim | 2018 |
Effects of the combination of metformin and exercise on glycated hemoglobin, functional capacity, lipid profile, quality of life, and body weight.
Topics: Aged; Biomarkers; Blood Glucose; Body Weight; Case-Control Studies; Combined Modality Therapy; Diabe | 2019 |
Long-term diabetes outcomes after bariatric surgery-managing medication withdrawl.
Topics: Adult; Bariatric Surgery; Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Human | 2019 |
Preventative effects of metformin on glucocorticoid-induced osteoporosis in rats.
Topics: Alendronate; Animals; Blood Glucose; Body Weight; Bone Density; Female; Femur; Glucocorticoids; Lipi | 2019 |
Metformin prevents nephrolithiasis formation by inhibiting the expression of OPN and MCP-1 in vitro and in vivo.
Topics: Animals; Body Weight; Cell Death; Chemokine CCL2; Disease Models, Animal; Dogs; Ethylene Glycol; Hum | 2019 |
Reply.
Topics: Body Weight; Diabetes Mellitus, Type 2; Humans; Insulin Glargine; Lipids; Liraglutide; Metformin; No | 2019 |
Letter to Editor: Role of Pharmacotherapy in Patients With Coexisting Nonalcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus.
Topics: Body Weight; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Insulin Glargine; Lipids; Lirag | 2019 |
Hepatoprotective effects of Cassia semen ethanol extract on non-alcoholic fatty liver disease in experimental rat.
Topics: Animals; Body Weight; Cassia; Liver; Male; Metformin; Non-alcoholic Fatty Liver Disease; Plant Extra | 2019 |
Developmental and Full-Life Cycle Exposures to Guanylurea and Guanylurea-Metformin Mixtures Results in Adverse Effects on Japanese Medaka (Oryzias latipes).
Topics: Animals; Body Weight; Female; Guanidines; Life Cycle Stages; Male; Metformin; Oryzias; Urea; Water P | 2019 |
The evidence of metabolic-improving effect of metformin in Ay/a mice with genetically-induced melanocortin obesity and the contribution of hypothalamic mechanisms to this effect.
Topics: Agouti-Related Protein; Animals; Body Weight; Female; Gene Expression Regulation; Hypoglycemic Agent | 2019 |
Metformin Attenuates Early-Stage Atherosclerosis in Mildly Hyperglycemic Oikawa-Nagao Mice.
Topics: Animals; Atherosclerosis; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Hyperglycem | 2019 |
Expert Opinion: Use of sodium glucose co-transporter type-2 inhibitors in South Asian population -The Pakistan perspective.
Topics: Asia, Southeastern; Asia, Western; Asian People; Blood Pressure; Body Weight; Cholesterol; Cholester | 2019 |
Incretin-Based Therapies for the Management of Nonalcoholic Fatty Liver Disease in Patients With Type 2 Diabetes.
Topics: Body Weight; Diabetes Mellitus, Type 2; Humans; Incretins; Insulin Glargine; Lipids; Liraglutide; Me | 2019 |
Maternal Metformin Treatment Improves Developmental and Metabolic Traits of IUGR Fetuses.
Topics: Animals; Body Size; Body Weight; Female; Fetal Growth Retardation; Fetus; Metformin; Organ Size; Pre | 2019 |
The combination of exercise training and sodium-glucose cotransporter-2 inhibition improves glucose tolerance and exercise capacity in a rodent model of type 2 diabetes.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 2; Dis | 2019 |
Endoplasmic reticulum stress-induced iRhom2 up-regulation promotes macrophage-regulated cardiac inflammation and lipid deposition in high fat diet (HFD)-challenged mice: Intervention of fisetin and metformin.
Topics: Animals; Body Weight; Carrier Proteins; Diet, High-Fat; Echocardiography; Endoplasmic Reticulum Stre | 2019 |
Lack of Durable Improvements in β-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes.
Topics: Adult; Arginine; B-Lymphocytes; Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; Fa | 2019 |
Lack of Durable Improvements in β-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes.
Topics: Adult; Arginine; B-Lymphocytes; Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; Fa | 2019 |
Lack of Durable Improvements in β-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes.
Topics: Adult; Arginine; B-Lymphocytes; Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; Fa | 2019 |
Lack of Durable Improvements in β-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes.
Topics: Adult; Arginine; B-Lymphocytes; Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; Fa | 2019 |
Ocimum kilimandscharicum L. restores ovarian functions in letrozole - induced Polycystic Ovary Syndrome (PCOS) in rats: Comparison with metformin.
Topics: Aged; Animals; Antioxidants; Aromatase Inhibitors; Blood Glucose; Body Weight; Chromatography, High | 2019 |
Evaluation of Kidney Function Parameters in Diabetic Rats Following Virgin Coconut Oil Diet.
Topics: Animals; Blood Urea Nitrogen; Body Weight; Coconut Oil; Creatinine; Diabetes Mellitus, Experimental; | 2019 |
Anti-diabetic effect of Murraya koenigii (L) and Olea europaea (L) leaf extracts on streptozotocin induced diabetic rats.
Topics: Administration, Oral; Animals; Biomarkers; Blood Glucose; Body Weight; Cholesterol; Creatinine; Diab | 2013 |
Prenatal metformin exposure in mice programs the metabolic phenotype of the offspring during a high fat diet at adulthood.
Topics: Animals; Body Weight; Diet, High-Fat; Eating; Female; Fetus; Gene Expression Regulation; Glucose Tol | 2013 |
Metformin inhibits the growth of human pancreatic cancer xenografts.
Topics: Administration, Oral; Animals; Blotting, Western; Body Weight; Cell Line, Tumor; Dose-Response Relat | 2013 |
Effect of metformin on the urinary metabolites of diet-induced-obese mice studied by ultra performance liquid chromatography coupled to time-of-flight mass spectrometry (UPLC-TOF/MS).
Topics: Animals; Blood Glucose; Body Weight; Chromatography, High Pressure Liquid; Diet, High-Fat; Male; Mas | 2013 |
Kidney function decline in metformin versus sulfonylurea initiators: assessment of time-dependent contribution of weight, blood pressure, and glycemic control.
Topics: Aged; Blood Glucose; Blood Pressure; Body Weight; Cohort Studies; Diabetes Mellitus, Type 2; Female; | 2013 |
Hypoglycemic and anti-hyperglycemic study of Gynura procumbens leaf extracts.
Topics: Animals; Asteraceae; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Flavonoids; Glucos | 2013 |
Effect of the combination of metformin and fenofibrate on glucose homeostasis in diabetic Goto-Kakizaki rats.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Drug Therapy, Combination; Exe | 2013 |
The combined effect of metformin and L-cysteine on inflammation, oxidative stress and insulin resistance in streptozotocin-induced type 2 diabetes in rats.
Topics: Animals; Body Weight; C-Reactive Protein; Caspase 3; Chemokine CCL2; Cysteine; Cytochromes c; Diabet | 2013 |
Effect of kolaviron, a biflavonoid complex from Garcinia kola seeds, on the antioxidant, hormonal and spermatogenic indices of diabetic male rats.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Drug Evaluation, Preclinical; | 2014 |
Angiotensin II receptor blocker telmisartan prevents new-onset diabetes in pre-diabetes OLETF rats on a high-fat diet: evidence of anti-diabetes action.
Topics: Angiotensin II Type 1 Receptor Blockers; Animals; Benzimidazoles; Benzoates; Blood Glucose; Blood Pr | 2013 |
Metformin inhibits skin tumor promotion in overweight and obese mice.
Topics: Adenylate Kinase; Adiponectin; Animals; Body Weight; Carcinogenesis; Carcinoma, Squamous Cell; Diet; | 2014 |
Changes in adiponectin level and fat distribution in patients with type 2 diabetes.
Topics: Adiponectin; Adipose Tissue; Aged; Blood Glucose; Body Fat Distribution; Body Weight; Diabetes Melli | 2014 |
Efficacy and safety of insulin glargine added to a fixed-dose combination of metformin and a dipeptidyl peptidase-4 inhibitor: results of the GOLD observational study.
Topics: Aged; Biomarkers; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inh | 2013 |
[Оptimization of stable angina standard therapy in patients with concomitant osteoarthritis and obesity].
Topics: Adult; Aged; Angina, Stable; Anti-Inflammatory Agents, Non-Steroidal; Body Mass Index; Body Weight; | 2013 |
[Effects of anti-diabetic therapy on overweight/obesity and dyslipidemia: traditional hypoglycemic agents (metformin, sulfonylureas, thiazolidinediones) versus glucagon-like peptide-1 analogs and dipeptidyl peptidase-4 inhibitors].
Topics: Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; | 2013 |
Characterization of the exocrine pancreas in the male Zucker diabetic fatty rat model of type 2 diabetes mellitus following 3 months of treatment with sitagliptin.
Topics: Administration, Oral; Animals; Blood Glucose; Body Weight; Cell Proliferation; Diabetes Mellitus, Ex | 2014 |
Modeling effects of SGLT-2 inhibitor dapagliflozin treatment versus standard diabetes therapy on cardiovascular and microvascular outcomes.
Topics: Amputation, Surgical; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Cardiovascul | 2014 |
KDT501, a derivative from hops, normalizes glucose metabolism and body weight in rodent models of diabetes.
Topics: Adipocytes; Animals; Blood Glucose; Body Weight; Cells, Cultured; Diabetes Mellitus, Experimental; D | 2014 |
Cardiovascular safety of combination therapies with incretin-based drugs and metformin compared with a combination of metformin and sulphonylurea in type 2 diabetes mellitus--a retrospective nationwide study.
Topics: Blood Glucose; Body Weight; Denmark; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; | 2014 |
Effect of vitamin D3 on behavioural and biochemical parameters in diabetes type 1-induced rats.
Topics: Acetylcholinesterase; Animals; Blood Glucose; Body Weight; Cerebral Cortex; Cholecalciferol; Diabete | 2014 |
SGLT-2 inhibitors as second-line therapy in type 2 diabetes.
Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Drug Th | 2014 |
Metformin impairs mitochondrial function in skeletal muscle of both lean and diabetic rats in a dose-dependent manner.
Topics: Animals; Body Weight; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 2; Humans; Insulin; M | 2014 |
Comparison of the independent and combined effects of sub-chronic therapy with metformin and a stable GLP-1 receptor agonist on cognitive function, hippocampal synaptic plasticity and metabolic control in high-fat fed mice.
Topics: Animals; Anxiety; Body Weight; CA1 Region, Hippocampal; Cognition; Diet, High-Fat; Drug Therapy, Com | 2014 |
Metformin suppresses lipid accumulation in skeletal muscle by promoting fatty acid oxidation.
Topics: Animals; Body Weight; Cell Line; Fatty Acids; Female; Lipid Metabolism; Male; Metformin; Mice; Mice, | 2014 |
Antidiabetic effects of the Cimicifuga racemosa extract Ze 450 in vitro and in vivo in ob/ob mice.
Topics: AMP-Activated Protein Kinases; Animals; Benzophenanthridines; Berberine Alkaloids; Blood Glucose; Bo | 2014 |
Effect of metformin on metabolic improvement and gut microbiota.
Topics: Animals; Biomarkers; Blood Glucose; Body Weight; Clostridium; Diabetes Mellitus, Experimental; Diabe | 2014 |
A follow-up of a randomised study of metformin and insulin in gestational diabetes mellitus: growth and development of the children at the age of 18 months.
Topics: Adult; Body Height; Body Weight; Child Development; Diabetes, Gestational; Female; Follow-Up Studies | 2015 |
Metformin reduces asymmetric dimethylarginine and prevents hypertension in spontaneously hypertensive rats.
Topics: Amidohydrolases; Animals; Arginine; Blood Pressure; Body Weight; Hypertension; Kidney; Lung; Male; M | 2014 |
Hypoglycemic effect of catalpol on high-fat diet/streptozotocin-induced diabetic mice by increasing skeletal muscle mitochondrial biogenesis.
Topics: Animals; Base Sequence; Body Weight; Diet, High-Fat; DNA Primers; DNA, Mitochondrial; Glucose Tolera | 2014 |
Metformin treatment improves weight and dyslipidemia in children with metabolic syndrome.
Topics: Adolescent; Body Mass Index; Body Weight; Child; Dyslipidemias; Humans; Hypoglycemic Agents; Metabol | 2015 |
Effect of metformin on sleep disorders in adolescent girls with polycystic ovarian syndrome.
Topics: Adolescent; Blood Glucose; Body Mass Index; Body Weight; Child; Female; Hirsutism; Humans; Hypoglyce | 2014 |
Protective effects of grape seed extract fractions with different degrees of polymerisation on blood glucose, lipids and hepatic oxidative stress in diabetic rats.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Grape Seed Extract; Lipids; Li | 2015 |
Economic implications of weight change in patients with type 2 diabetes mellitus.
Topics: Body Weight; Cost Savings; Diabetes Mellitus, Type 2; Female; Health Care Costs; Humans; Hypoglycemi | 2014 |
Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: data from the Italian AIFA Anti-diabetics Monitoring Registry.
Topics: Adamantane; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Utilization; Drug-Rela | 2014 |
Is insulin the most effective injectable antihyperglycaemic therapy?
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Exenatide; Fasting; Female; Glucagon-Like Pep | 2015 |
What is the best approach to glycaemic control in patients with type 2 diabetes?
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Hypoglyc | 2015 |
Observational and clinical trial findings on the comparative effectiveness of diabetes drugs showed agreement.
Topics: Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Me | 2015 |
Sex differences in aging, life span and spontaneous tumorigenesis in 129/Sv mice neonatally exposed to metformin.
Topics: Aging; Animals; Animals, Newborn; Body Temperature; Body Weight; Cell Transformation, Neoplastic; Es | 2015 |
Metformin alleviates hepatosteatosis by restoring SIRT1-mediated autophagy induction via an AMP-activated protein kinase-independent pathway.
Topics: AMP-Activated Protein Kinases; Animals; Autophagy; Blood Glucose; Body Weight; Caloric Restriction; | 2015 |
Intracerebroventricular metformin decreases body weight but has pro-oxidant effects and decreases survival.
Topics: Animals; Body Weight; Cells, Cultured; Hypoglycemia; Hypoglycemic Agents; Infusions, Intraventricula | 2015 |
Should sulfonylureas remain an acceptable first-line add-on to metformin therapy in patients with type 2 diabetes? No, it's time to move on!
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Feeding Behavior; Humans; Hyperglycemia; Hypo | 2015 |
Prenatal metformin exposure in a maternal high fat diet mouse model alters the transcriptome and modifies the metabolic responses of the offspring.
Topics: Adipocytes; Adipokines; Adipose Tissue, White; Animals; Blood Glucose; Body Weight; Cell Size; Diet, | 2014 |
Metformin and Rapamycin Reduce Pancreatic Cancer Growth in Obese Prediabetic Mice by Distinct MicroRNA-Regulated Mechanisms.
Topics: Animals; Body Weight; Cell Cycle; Diet, Diabetic; Energy Intake; Glucose Intolerance; Hypoglycemic A | 2015 |
Clinical effectiveness and safety of vildagliptin in >19 000 patients with type 2 diabetes: the GUARD study.
Topics: Adamantane; Adult; Aged; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Dru | 2015 |
Correlation between baseline characteristics and clinical outcomes in a large population of diabetes patients treated with liraglutide in a real-world setting in Italy.
Topics: Aged; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemog | 2015 |
Synergistic Effects of a GPR119 Agonist with Metformin on Weight Loss in Diet-Induced Obese Mice.
Topics: Animals; Body Weight; Diet, High-Fat; Dose-Response Relationship, Drug; Drug Synergism; Eating; Gast | 2015 |
Combination therapy with oleanolic acid and metformin as a synergistic treatment for diabetes.
Topics: Animals; Biomarkers; Body Weight; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 2; Diseas | 2015 |
Add-On Treatment with Liraglutide Improves Glycemic Control in Patients with Type 2 Diabetes on Metformin Therapy.
Topics: Aged; Blood Glucose; Blood Glucose Self-Monitoring; Blood Pressure; Body Weight; Diabetes Mellitus, | 2015 |
The influence of age and metformin treatment status on reported gastrointestinal side effects with liraglutide treatment in type 2 diabetes.
Topics: Adult; Age Factors; Aged; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; | 2015 |
Alpha-lipoic acid reduces body weight and regulates triglycerides in obese patients with diabetes mellitus.
Topics: Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Female; Humans; Male; Metformin; Middle Aged; O | 2015 |
[THE EFFECTS OF LONG-TERM METFORMIN TREATMENT ON THE ACTIVITY OF ADENYLYL CYCLASE SYSTEM AND NO-SYNTHASES IN THE BRAIN AND THE MYOCARDIUM OF RATS WITH OBESITY].
Topics: Adenylyl Cyclases; Adipose Tissue; Adrenergic Agonists; Animals; Body Weight; Brain; Cardiotonic Age | 2015 |
Hyperandrogenism and Insulin Resistance, Not Changes in Body Weight, Mediate the Development of Endothelial Dysfunction in a Female Rat Model of Polycystic Ovary Syndrome (PCOS).
Topics: Androgen Antagonists; Androgens; Animals; Arteries; Blood Pressure; Body Weight; Dihydrotestosterone | 2015 |
Use of Renally Inappropriate Medications in Older Veterans: A National Study.
Topics: Aged; Aged, 80 and over; Allopurinol; Aminohydrolases; Body Weight; Comorbidity; Cross-Sectional Stu | 2015 |
Metformin for treatment of antipsychotic-induced weight gain in a South Asian population with schizophrenia or schizoaffective disorder: A double blind, randomized, placebo controlled study.
Topics: Adult; Antipsychotic Agents; Blood Glucose; Body Mass Index; Body Weight; Double-Blind Method; Femal | 2015 |
Metformin inhibits early stage diethylnitrosamine‑induced hepatocarcinogenesis in rats.
Topics: Adenylate Kinase; Animals; Blotting, Western; Body Weight; Carcinogenesis; Carcinoma, Hepatocellular | 2016 |
Does metformin improve in vitro maturation and ultrastructure of oocytes retrieved from estradiol valerate polycystic ovary syndrome-induced rats.
Topics: Animals; Blood Glucose; Body Weight; Contraceptive Agents; Cumulus Cells; Disease Models, Animal; Es | 2015 |
The effect of metformin on neuronal activity in the appetite-regulating brain regions of mice fed a high-fat diet during an anorectic period.
Topics: Analysis of Variance; Animals; Anorexia; Body Weight; Brain; Diet, High-Fat; Eating; Gene Expression | 2016 |
Cardioprotective effect of metformin in lipopolysaccharide-induced sepsis via suppression of toll-like receptor 4 (TLR4) in heart.
Topics: AMP-Activated Protein Kinases; Animals; Body Weight; Cardiotonic Agents; Gene Expression Regulation; | 2016 |
Determinants of Glycemic Response to Add-On Therapy with a Dipeptidyl Peptidase-4 Inhibitor: A Retrospective Cohort Study Using a United Kingdom Primary Care Database.
Topics: Aged; Blood Glucose; Body Weight; Databases, Factual; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidas | 2016 |
[Metformin and changes in blood pressure and heart rate in lean patients with polycystic ovary syndrome (PCOS)--preliminary study].
Topics: Adolescent; Blood Pressure; Body Weight; Female; Heart Rate; Humans; Hypoglycemic Agents; Metformin; | 2015 |
Effects of Exenatide on Metabolic Changes, Sexual Hormones, Inflammatory Cytokines, Adipokines, and Weight Change in a DHEA-Treated Rat Model.
Topics: Adipokines; Animals; Body Weight; Cytokines; Dehydroepiandrosterone; Disease Models, Animal; Exenati | 2016 |
Important differences in the durability of glycaemic response among second-line treatment options when added to metformin in type 2 diabetes: a retrospective cohort study.
Topics: Aged; Blood Glucose; Body Weight; Cohort Studies; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV | 2016 |
Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks.
Topics: Adiposity; Aged; Body Composition; Body Mass Index; Body Weight; Canagliflozin; Clinical Trials, Pha | 2016 |
Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks.
Topics: Adiposity; Aged; Body Composition; Body Mass Index; Body Weight; Canagliflozin; Clinical Trials, Pha | 2016 |
Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks.
Topics: Adiposity; Aged; Body Composition; Body Mass Index; Body Weight; Canagliflozin; Clinical Trials, Pha | 2016 |
Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks.
Topics: Adiposity; Aged; Body Composition; Body Mass Index; Body Weight; Canagliflozin; Clinical Trials, Pha | 2016 |
Metformin Prevents Fatty Liver and Improves Balance of White/Brown Adipose in an Obesity Mouse Model by Inducing FGF21.
Topics: 3T3-L1 Cells; Adipose Tissue; Adiposity; Animals; Body Weight; CD4-Positive T-Lymphocytes; Diet, Hig | 2016 |
Association Between Weight Change, Clinical Outcomes, and Health Care Costs in Patients with Type 2 Diabetes.
Topics: Blood Pressure; Body Weight; Cardiovascular Diseases; Cholesterol, LDL; Cohort Studies; Diabetes Mel | 2016 |
Effect of Vanadyl Rosiglitazone, a New Insulin-Mimetic Vanadium Complexes, on Glucose Homeostasis of Diabetic Mice.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Disease Models, Animal; Drinki | 2016 |
Addition of sulphonylurea to metformin does not relevantly change body weight: a prospective observational cohort study (ZODIAC-39).
Topics: Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glyc | 2016 |
Changes in Levels of Biomarkers Associated with Adipocyte Function and Insulin and Glucagon Kinetics During Treatment with Dapagliflozin Among Obese Type 2 Diabetes Mellitus Patients.
Topics: Adipocytes; Adiponectin; Adult; Benzhydryl Compounds; Biomarkers; Blood Glucose; Body Weight; C-Reac | 2016 |
Additional effect of metformin and celecoxib against lipid dysregulation and adipose tissue inflammation in high-fat fed rats with insulin resistance and fatty liver.
Topics: Adipocytes; Adipokines; Adipose Tissue; AMP-Activated Protein Kinases; Animals; Blood Pressure; Body | 2016 |
The paraoxonase 1 (PON1), platelet-activating factor acetylohydrolase (PAF-AH) and dimethylarginine dimethylaminohydrolase (DDAH) activity in the metformin treated normal and diabetic rats.
Topics: 1-Alkyl-2-acetylglycerophosphocholine Esterase; Amidohydrolases; Animals; Aryldialkylphosphatase; Bo | 2016 |
Metformin ameliorates obesity-associated hypertriglyceridemia in mice partly through the apolipoprotein A5 pathway.
Topics: Animals; Apolipoprotein A-V; Body Weight; Hep G2 Cells; Humans; Hypertriglyceridemia; Male; Metformi | 2016 |
Antidiabetic effects of Cuscuta reflexa Roxb. in streptozotocin induced diabetic rats.
Topics: Animals; Biomarkers; Blood Glucose; Body Weight; Cuscuta; Diabetes Mellitus, Experimental; Dose-Resp | 2016 |
Accumulation of methylglyoxal and d-lactate in Pb-induced nephrotoxicity in rats.
Topics: Animals; Biomarkers; Body Weight; Creatinine; Kidney; Kidney Diseases; L-Lactate Dehydrogenase; Lact | 2017 |
Pleiotropic protective effects of Vitamin D against high fat diet-induced metabolic syndrome in rats: One for all.
Topics: Animals; Biomarkers; Body Weight; Calcium; Cytoprotection; Diet, High-Fat; Drug Interactions; Hypert | 2016 |
Metformin Reduces Lipogenesis Markers in Obese Mice Fed a Low-Carbohydrate and High-Fat Diet.
Topics: Acetyl-CoA Carboxylase; Adipose Tissue; Administration, Oral; Animals; Biomarkers; Body Weight; Diet | 2016 |
Metformin preconditioned adipose derived mesenchymal stem cells is a better option for the reversal of diabetes upon transplantation.
Topics: Adipose Tissue; Animals; Blood Glucose; Body Weight; Cytokines; Diabetes Mellitus, Type 2; Diet, Hig | 2016 |
Lean Body Weight and Metformin Are Insufficient to Prevent Endometrial Hyperplasia in Mice Harboring Inactivating Mutations in PTEN.
Topics: Adiponectin; Animals; Body Weight; Endometrial Hyperplasia; Female; Hypoglycemic Agents; Metformin; | 2017 |
Predictors of menstruation restoration during metformin administration for treatment of antipsychotic drug-induced amenorrhea: A post hoc analysis.
Topics: Amenorrhea; Antipsychotic Agents; Body Weight; Female; Follicle Stimulating Hormone; Humans; Hypogly | 2017 |
Adiponectin receptors: expression in Zucker diabetic rats and effects of fenofibrate and metformin.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Eating; Fatty Acids, Nonesteri | 2008 |
Strategies to control antipsychotic-induced weight gain.
Topics: Anti-Obesity Agents; Antipsychotic Agents; Awareness; Body Weight; Bupropion; Clinical Competence; F | 2008 |
Metformin protects the brain against the oxidative imbalance promoted by type 2 diabetes.
Topics: Animals; Blood Glucose; Body Weight; Brain; Diabetes Mellitus, Type 2; Glutathione; Hydrogen Peroxid | 2008 |
Effect of FeSO4 treatment on glucose metabolism in diabetic rats.
Topics: Animals; Blood Glucose; Body Weight; Citric Acid Cycle; Diabetes Mellitus, Experimental; Electron Tr | 2008 |
No effect of metformin on the innate airway hyperresponsiveness and increased responses to ozone observed in obese mice.
Topics: Administration, Oral; Animals; Asthma; Blood Glucose; Body Weight; Bronchial Hyperreactivity; Bronch | 2008 |
Metformin slows down aging and extends life span of female SHR mice.
Topics: Aging; Animals; Body Temperature; Body Weight; Drinking Behavior; Estrous Cycle; Feeding Behavior; F | 2008 |
Nigella sativa inhibits intestinal glucose absorption and improves glucose tolerance in rats.
Topics: Animals; Body Weight; Dose-Response Relationship, Drug; Female; Glucose; Glucose Tolerance Test; Hyp | 2009 |
Effects of basal insulin analog and metformin on glycaemia control and weight as risk factors for endothelial dysfunction.
Topics: Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Endothelium, Vascula | 2008 |
Comparative therapeutic effects of metformin and vitamin E in a model of non-alcoholic steatohepatitis in the young rat.
Topics: Animals; Antioxidants; Blotting, Western; Body Weight; Disease Models, Animal; Fatty Liver; Lipid Pe | 2009 |
Effect of chronic co-administration of metformin and vitamin C on plasma glucose and lipid concentrations in normal rats.
Topics: Administration, Oral; Animals; Ascorbic Acid; Blood Glucose; Body Weight; Drug Therapy, Combination; | 2007 |
db/+ Mice as an alternate model in antidiabetic drug discovery research.
Topics: Animals; Body Weight; Diabetes Mellitus, Experimental; Disease Models, Animal; Drug Discovery; Gluco | 2009 |
[Metformin also as first choice in patients with normal weight. Has its use increased?].
Topics: Body Weight; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Longitudinal Studies; Metformin | 2009 |
Nonalcoholic hepatic steatosis in Zucker diabetic rats: spontaneous evolution and effects of metformin and fenofibrate.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Disease Models, Animal; Eating | 2009 |
Androgen receptor antagonism and an insulin sensitizer block the advancement of vaginal opening by high-fat diet in mice.
Topics: Analysis of Variance; Androgen Antagonists; Animals; Body Weight; Diet, Fat-Restricted; Dietary Fats | 2009 |
Total and acylated ghrelin levels in type 2 diabetic patients: similar levels observed after treatment with metformin, pioglitazone or diet therapy.
Topics: Acylation; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Female; Ghrelin; | 2009 |
Pregnancy outcomes in women with gestational diabetes treated with metformin or insulin: a case-control study.
Topics: Birth Weight; Blood Glucose; Body Weight; Case-Control Studies; Diabetes, Gestational; Female; Human | 2009 |
Conjugated linoleic acid activates AMP-activated protein kinase and reduces adiposity more effectively when used with metformin in mice.
Topics: 3T3 Cells; Adipocytes; AMP-Activated Protein Kinases; Animals; Body Weight; Cell Culture Techniques; | 2009 |
Lipase maturation factor 1: its expression in Zucker diabetic rats, and effects of metformin and fenofibrate.
Topics: Adipose Tissue; Analysis of Variance; Animals; Blood Glucose; Body Weight; Diabetes Mellitus; Enzyme | 2009 |
Toxicity and toxicokinetics of metformin in rats.
Topics: Animals; Area Under Curve; Blood Cell Count; Blood Chemical Analysis; Body Weight; Chromatography, H | 2010 |
Treatment with sitagliptin or metformin does not increase body weight despite predicted reductions in urinary glucose excretion.
Topics: Body Weight; Diabetes Mellitus, Type 2; Glucose; Humans; Hypoglycemic Agents; Metformin; Models, The | 2009 |
Metformin normalizes type 2 diabetes-induced decrease in cell proliferation and neuroblast differentiation in the rat dentate gyrus.
Topics: Animals; Blood Glucose; Body Weight; Cell Proliferation; Dentate Gyrus; Diabetes Mellitus, Experimen | 2010 |
Effects of metformin on serum levels of sex hormone, leptin and insulin in ovariectomized Sprague-Dawley rats.
Topics: Animals; Body Weight; Estradiol; Female; Gonadal Steroid Hormones; Hypoglycemic Agents; Insulin; Lep | 2009 |
The anorexigenic effects of metformin involve increases in hypothalamic leptin receptor expression.
Topics: Agouti-Related Protein; Animals; Blood Glucose; Body Weight; Eating; Humans; Hypoglycemic Agents; Hy | 2011 |
Metformin supplementation and life span in Fischer-344 rats.
Topics: Animals; Blood Glucose; Body Temperature; Body Weight; Eating; Food Additives; Hypoglycemic Agents; | 2010 |
Understanding the inter-relationship between improved glycaemic control, hypoglycaemia and weight change within a long-term economic model.
Topics: Blood Glucose; Body Weight; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Humans; Hypoglycemia; | 2010 |
Metformin reduces body weight gain and improves glucose intolerance in high-fat diet-fed C57BL/6J mice.
Topics: Animals; Blood Glucose; Body Weight; Dietary Fats; Energy Intake; Glucagon-Like Peptide 1; Glucose I | 2010 |
Hyperinsulinemia precedes insulin resistance in mice lacking pancreatic beta-cell leptin signaling.
Topics: Adiposity; Animals; Blood Glucose; Body Weight; Diazoxide; Eating; Female; Hyperinsulinism; Hypoglyc | 2010 |
Effects of metformin on rosiglitazone-induced cardiac hypertrophy in mice.
Topics: Animals; Body Weight; Cardiomegaly; Drug Therapy, Combination; Eating; Male; Metformin; Mice; Mice, | 2010 |
Countering side effects.
Topics: Antipsychotic Agents; Body Weight; Humans; Hypoglycemic Agents; Metabolic Syndrome; Metformin; Psych | 2010 |
Glycemic and weight changes after persistent use of incident oral diabetes therapy: a Veterans Administration retrospective cohort study.
Topics: Administration, Oral; Aged; Blood Glucose; Body Mass Index; Body Weight; Cohort Studies; Diabetes Me | 2010 |
[Effect of metformin on the formation of hepatic fibrosis in type 2 diabetic rats].
Topics: Actins; Animals; Apoptosis; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Diabetes Me | 2010 |
Effect of combining rosiglitazone with either metformin or insulin on β-cell mass and function in an animal model of Type 2 diabetes characterized by reduced β-cell mass at birth.
Topics: Adiposity; Analysis of Variance; Animals; Animals, Newborn; Blood Glucose; Body Weight; Diabetes Mel | 2011 |
Pronounced weight gain in insulin-treated patients with type 2 diabetes mellitus is associated with an unfavourable cardiometabolic risk profile.
Topics: Aged; Body Fat Distribution; Body Weight; Cardiovascular Diseases; Cross-Sectional Studies; Diabetes | 2010 |
Summaries for patients: Does adding exenatide to insulin treatment benefit patients with type 2 diabetes?
Topics: Aged; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Combinatio | 2011 |
Gender differences in metformin effect on aging, life span and spontaneous tumorigenesis in 129/Sv mice.
Topics: Age Factors; Aging; Animals; Blood Glucose; Body Temperature; Body Weight; Cholesterol; Chromosome A | 2010 |
Insulin and metformin may prevent renal injury in young type 2 diabetic Goto-Kakizaki rats.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 2; Dia | 2011 |
Metformin and atorvastatin combination further protect the liver in type 2 diabetes with hyperlipidaemia.
Topics: Animals; Anticholesteremic Agents; Atorvastatin; Body Weight; C-Reactive Protein; Diabetes Complicat | 2011 |
Protection of cholinergic and antioxidant system contributes to the effect of berberine ameliorating memory dysfunction in rat model of streptozotocin-induced diabetes.
Topics: Acetylcholine; Administration, Oral; Analysis of Variance; Animals; Antioxidants; Ascorbic Acid; Ber | 2011 |
Effect of metformin therapy on cardiac function and survival in a volume-overload model of heart failure in rats.
Topics: AMP-Activated Protein Kinase Kinases; Animals; Blood Glucose; Body Weight; Disease Models, Animal; D | 2011 |
Management of cardiovascular risk factors with pioglitazone combination therapies in type 2 diabetes: an observational cohort study.
Topics: Aged; Biomarkers; Blood Glucose; Blood Pressure; Body Mass Index; Body Weight; Cardiovascular Diseas | 2011 |
Anti-diabetic effects of mildronate alone or in combination with metformin in obese Zucker rats.
Topics: Animals; Blood Glucose; Body Weight; Cell Nucleus; Drug Combinations; Eating; Gene Expression Regula | 2011 |
If started early in life, metformin treatment increases life span and postpones tumors in female SHR mice.
Topics: Age Factors; Animals; Body Temperature; Body Weight; Drinking; Eating; Estrous Cycle; Female; Humans | 2011 |
Glibenclamide or metformin combined with honey improves glycemic control in streptozotocin-induced diabetic rats.
Topics: Animals; Bilirubin; Blood Glucose; Body Weight; Creatinine; Diabetes Mellitus, Experimental; Eating; | 2011 |
Investigation of the potential effects of metformin on atherothrombotic risk factors in hyperlipidemic rats.
Topics: Animals; Antioxidants; Aorta; Atherosclerosis; Blood Coagulation; Body Weight; Carotid Arteries; Cho | 2011 |
The effect of metformin on the myocardial tolerance to ischemia-reperfusion injury in the rat model of diabetes mellitus type II.
Topics: Animals; Animals, Newborn; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Disease Mode | 2011 |
Reduced cell proliferation and neuroblast differentiation in the dentate gyrus of high fat diet-fed mice are ameliorated by metformin and glimepiride treatment.
Topics: Animals; Body Weight; Brain-Derived Neurotrophic Factor; Cell Differentiation; Cell Proliferation; D | 2011 |
Metformin treatment has no beneficial effect in a dose-response survival study in the SOD1(G93A) mouse model of ALS and is harmful in female mice.
Topics: Aging; Amino Acid Substitution; Amyotrophic Lateral Sclerosis; Animals; Body Weight; Cell Count; Dis | 2011 |
Hypoglycaemic activity and molecular mechanisms of Caesalpinia ferrea Martius bark extract on streptozotocin-induced diabetes in Wistar rats.
Topics: Acetyl-CoA Carboxylase; Administration, Oral; AMP-Activated Protein Kinases; Animals; Blood Glucose; | 2011 |
Insulin sensitizers may attenuate lean mass loss in older men with diabetes.
Topics: Absorptiometry, Photon; Adipose Tissue; Aged; Aged, 80 and over; Aging; Blood Glucose; Body Composit | 2011 |
Metformin regulates hepatic lipid metabolism through activating AMP-activated protein kinase and inducing ATGL in laying hens.
Topics: Abdominal Fat; AMP-Activated Protein Kinases; Animals; Body Weight; Chickens; Eating; Enzyme Activat | 2011 |
Drug treatment of obesity.
Topics: Adolescent; Adult; Anti-Obesity Agents; Antidepressive Agents, Second-Generation; Body Weight; Bupro | 2011 |
Improvement of metabolic parameters and vascular function by metformin in obese non-diabetic rats.
Topics: Acetylcholine; Animals; Blood Pressure; Body Weight; Disease Models, Animal; Dyslipidemias; Epoprost | 2012 |
Population pharmacokinetics of metformin in obese and non-obese patients with type 2 diabetes mellitus.
Topics: Adult; Aged; Aged, 80 and over; Body Weight; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemic | 2012 |
Anti-diabetic activities of Acanthopanax senticosus polysaccharide (ASP) in combination with metformin.
Topics: Animals; Bilirubin; Blood Glucose; Body Weight; Creatinine; Diabetes Mellitus, Experimental; Drug In | 2012 |
Therapeutic trial of metformin and bortezomib in a mouse model of tuberous sclerosis complex (TSC).
Topics: Animals; Body Weight; Boronic Acids; Bortezomib; Disease Models, Animal; Humans; Immunoblotting; Imm | 2012 |
Downregulation of chemerin and alleviation of endoplasmic reticulum stress by metformin in adipose tissue of rats.
Topics: Adipokines; Adipose Tissue; Animals; Blood Glucose; Body Weight; Chemokines; Diet, High-Fat; Down-Re | 2012 |
Cardioprotective effects of metformin and vildagliptin in adult rats with insulin resistance induced by a high-fat diet.
Topics: Adamantane; Animals; Blood Glucose; Body Weight; Diet, High-Fat; Dipeptidyl-Peptidase IV Inhibitors; | 2012 |
Attenuation of insulin resistance, metabolic syndrome and hepatic oxidative stress by resveratrol in fructose-fed rats.
Topics: Animals; Ascorbic Acid; Blood Glucose; Body Weight; Catalase; Eating; Fructose; Glucose Tolerance Te | 2012 |
A high-fat-diet-induced cognitive deficit in rats that is not prevented by improving insulin sensitivity with metformin.
Topics: Alzheimer Disease; Animals; Behavior, Animal; Body Weight; Brain; Cognition Disorders; Conditioning, | 2012 |
[Pharmacogenetic features of the effect of metformin in patients with coronary heart disease in the presence of metabolic syndrome and type 2 diabetes mellitus in terms of PPAR-gamma2 gene polymorphism].
Topics: Aged; Alleles; Body Weight; Case-Control Studies; Coronary Disease; Cytokines; Diabetes Mellitus, Ty | 2012 |
Gemfibrozil and its combination with metformin on pleiotropic effect on IL-10 and adiponectin and anti-atherogenic treatment in insulin resistant type 2 diabetes mellitus rats.
Topics: Adiponectin; Animals; Body Weight; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 2; Drug | 2013 |
Role of PKC and CaV1.2 in detrusor overactivity in a model of obesity associated with insulin resistance in mice.
Topics: Adiposity; Amlodipine; Animals; Body Weight; Calcium Channel Blockers; Calcium Channels, L-Type; Cal | 2012 |
Renal uptake of substrates for organic anion transporters Oat1 and Oat3 and organic cation transporters Oct1 and Oct2 is altered in rats with adenine-induced chronic renal failure.
Topics: Adenine; Animals; Anti-Bacterial Agents; Body Weight; Gene Expression; Hypoglycemic Agents; Kidney; | 2013 |
Metformin temporal and localized effects on gut glucose metabolism assessed using 18F-FDG PET in mice.
Topics: Animals; Blood Glucose; Body Weight; Carrier Proteins; Female; Fluorodeoxyglucose F18; Gastrointesti | 2013 |
Nateglinide in combination with metformin in Chinese patients with type 2 diabetes mellitus: a post-marketing surveillance study.
Topics: Aged; Body Weight; Cyclohexanes; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemic Agents; Mal | 2013 |
Metformin decreases meal size and number and increases c-Fos expression in the nucleus tractus solitarius of obese mice.
Topics: Animals; Avoidance Learning; Body Weight; Circadian Rhythm; Dietary Fats; Eating; Energy Intake; Ene | 2013 |
Durability of efficacy and long-term safety profile of glyburide/metformin tablets in patients with type 2 diabetes mellitus: an open-label extension study.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug Therap | 2002 |
Therapeutic approach in insulin resistance with acanthosis nigricans.
Topics: Acanthosis Nigricans; Adolescent; Adult; Body Mass Index; Body Weight; Diabetes Complications; Diabe | 2002 |
Transfer of metformin into human milk.
Topics: Adult; Body Weight; Breast Feeding; Child, Preschool; Chromatography, High Pressure Liquid; Diabetes | 2002 |
Is programming of glucocorticoid receptor expression by prenatal dexamethasone in the rat secondary to metabolic derangement in adulthood?
Topics: Animals; Appetite; Body Weight; Corticosterone; Dexamethasone; Female; Gene Expression; Glucocortico | 2003 |
Hypoglycemia and reduced feed intake in broiler chickens treated with metformin.
Topics: Animals; Blood Glucose; Body Weight; Chickens; Eating; Fatty Acids, Nonesterified; Glucagon; Insulin | 2003 |
Type 2 diabetes presenting as diabetic ketoacidosis in adolescence.
Topics: Acanthosis Nigricans; Adolescent; Blood Glucose; Body Weight; C-Peptide; Diabetes Mellitus, Type 2; | 2003 |
Long-term efficacy of steady-dose metformin in type 2 diabetes mellitus: a retrospective study.
Topics: Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Follow-Up Studies; Humans | 2003 |
Metformin, pre-eclampsia, and pregnancy outcomes in women with polycystic ovary syndrome.
Topics: Adult; Birth Weight; Body Weight; Diabetes, Gestational; Female; Gestational Age; HELLP Syndrome; Hu | 2004 |
Effect of N-benzoyl-D-phenylalanine and metformin on carbohydrate metabolic enzymes in neonatal streptozotocin diabetic rats.
Topics: Animals; Animals, Newborn; Blood Glucose; Body Weight; Carbohydrate Metabolism; Diabetes Mellitus, E | 2005 |
Effect of metformin on the clinical and metabolic assessment of women with polycystic ovary syndrome.
Topics: Adolescent; Adult; Blood Glucose; Body Mass Index; Body Weight; Female; Glucose Tolerance Test; Huma | 2004 |
[Short-term and long-term effect of metformin in type 1 diabetics].
Topics: Adult; Body Weight; Diabetes Mellitus, Type 1; Drug Therapy, Combination; Follow-Up Studies; Humans; | 2001 |
Metformin treatment restores the altered microvascular reactivity in neonatal streptozotocin-induced diabetic rats increasing NOS activity, but not NOS expression.
Topics: Animals; Animals, Newborn; Body Weight; Capillaries; Diabetes Mellitus, Experimental; Eating; Glucos | 2005 |
Rosiglitazone plus metformin is effective and well tolerated in clinical practice: results from large observational studies in people with type 2 diabetes.
Topics: Aged; Blood Pressure; Body Weight; Cohort Studies; Diabetes Mellitus, Type 2; Drug Therapy, Combinat | 2005 |
Tissue-specific regulation of malonyl-CoA decarboxylase activity in OLETF rats.
Topics: Animals; Body Weight; Carboxy-Lyases; Cholesterol; Fasting; Fatty Acids, Nonesterified; Glucose; Hyp | 2006 |
Stability of body weight in type 2 diabetes.
Topics: Adult; Aged; Body Mass Index; Body Weight; Diabetes Mellitus, Type 2; Humans; Insulin; Male; Metform | 2006 |
Treatment escalation and rise in HbA1c following successful initial metformin therapy.
Topics: Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Ma | 2006 |
Prenatal growth restraint followed by catch-up of weight: a hyperinsulinemic pathway to polycystic ovary syndrome.
Topics: Aging; Androgen Antagonists; Body Weight; Child; Drug Therapy, Combination; Female; Fetal Developmen | 2006 |
Changes in patient weight and the impact of antidiabetic therapy during the first 5 years after diagnosis of diabetes mellitus.
Topics: Age Factors; Aged; Body Mass Index; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Femal | 2006 |
Effects of glibornuride versus metformin on eye lenses and skin in experimental diabetes.
Topics: Animals; Blood Glucose; Body Weight; Crystallins; Diabetes Mellitus, Experimental; Electrophoresis, | 2006 |
Anti-diabetic effects of Sutherlandia frutescens in Wistar rats fed a diabetogenic diet.
Topics: Anesthesia; Animals; Blood Glucose; Body Weight; Diet; Dietary Fats; Glucose; Glycogen; Hyperinsulin | 2007 |
The CC genotype of the GNAS T393C polymorphism is associated with obesity and insulin resistance in women with polycystic ovary syndrome.
Topics: Androgens; Body Weight; Chromogranins; Female; Genotype; GTP-Binding Protein alpha Subunits, Gs; Hum | 2006 |
Long-term efficacy of metformin therapy in nonobese individuals with type 2 diabetes.
Topics: Administration, Oral; Aged; Blood Glucose; Body Mass Index; Body Weight; Databases, Factual; Diabete | 2006 |
Weight changes following the initiation of new anti-hyperglycaemic therapies.
Topics: Adult; Aged; Body Weight; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; Humans; Hypoglycemic | 2007 |
Sleep apnea is induced by a high-fat diet and reversed and prevented by metformin in non-obese rats.
Topics: Animals; Body Weight; Diet, Atherogenic; Dietary Fats; Drug Evaluation, Preclinical; Hypoglycemic Ag | 2007 |
Metformin improves polycystic ovary syndrome symptoms irrespective of pre-treatment insulin resistance.
Topics: Body Weight; Female; Humans; Insulin Resistance; Metformin; Obesity; Overweight; Polycystic Ovary Sy | 2007 |
Clinical predictors of disease progression and medication initiation in untreated patients with type 2 diabetes and A1C less than 7%.
Topics: Age Factors; Aged; Body Weight; Diabetes Mellitus, Type 2; Disease Progression; Female; Glycated Hem | 2008 |
Clinical decisions. Management of type 2 diabetes--polling results.
Topics: Body Weight; Cost-Benefit Analysis; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Exenatide; | 2008 |
Plasma high density lipoprotein cholesterol in streptozotocin diabetic and non-diabetic mice after prolonged administration of glibenclamide, chlorpropamide and metformin.
Topics: Animals; Blood Glucose; Body Weight; Chlorpropamide; Cholesterol; Cholesterol, HDL; Diabetes Mellitu | 1981 |
[Effect of long-term metformin treatment on the development of diabetes in genetically diabetic mice (DBM) (author's transl)].
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus; Female; Glycated Hemoglobin; Insulin; Islets | 1981 |
General practice care of non-insulin-dependent diabetes with fasting blood glucose measurements.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus; Family Practice; Fasting; Female; Glycat | 1982 |
Metformin induces an agonist-specific increase in albumin production by primary cultured rat hepatocytes.
Topics: Albumins; Animals; Body Weight; Cell Survival; Cells, Cultured; Epidermal Growth Factor; Insulin; In | 1995 |
Effects of metformin treatment on glucose transporter proteins in subcellular fractions of skeletal muscle in (fa/fa) Zucker rats.
Topics: Animals; Blood Glucose; Body Weight; Feeding Behavior; Glucose Transporter Type 1; Glucose Transport | 1995 |
Anorectic effect of metformin in obese Zucker rats: lack of evidence for the involvement of neuropeptide Y.
Topics: Administration, Oral; Animals; Appetite Depressants; Blood Glucose; Body Weight; Drinking; Eating; H | 1995 |
Metformin decreases plasma insulin levels and systolic blood pressure in spontaneously hypertensive rats.
Topics: Aging; Animals; Blood Glucose; Body Weight; Hypertension; Insulin; Insulin Secretion; Male; Metformi | 1994 |
[Metformin undervalued].
Topics: Aged; Body Weight; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Metformin; Middle Aged | 1996 |
Metformin decreases blood pressure and obesity in OLETF rats via improvement of insulin resistance.
Topics: Aging; Animals; Blood Glucose; Blood Pressure; Blotting, Northern; Body Weight; Diabetes Mellitus, T | 1996 |
Prevention of hyperglycemia in the Zucker diabetic fatty rat by treatment with metformin or troglitazone.
Topics: Age Factors; Animals; Body Weight; Chromans; Diabetes Mellitus, Type 2; Fatty Acids, Nonesterified; | 1996 |
[The effect of metformin on lactate levels in type II diabetes].
Topics: Body Weight; Cholesterol; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Humans; Hypoglycemic Agent | 1996 |
[Comparison of two treatment models in type-II diabetic patients with poor metabolic control: Preformed combination of glibenclamide 2,5 mg + metformin 400 mg or mono-therapy with sulfonylurea at maximal doses? An evaluation at six months].
Topics: Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Combinatio | 1996 |
Increased alanine uptake and lipid synthesis from alanine in isolated hepatocytes of Wistar-Kyoto fatty rats: an inhibitory effect of biguanides.
Topics: Aging; Alanine; Animals; Body Weight; Buformin; Cells, Cultured; Diabetes Mellitus, Experimental; Di | 1997 |
A retrospective analysis of the efficacy and safety of metformin in the African-American patient.
Topics: Adult; Aged; Aged, 80 and over; Black People; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, | 1997 |
Effect of masoprocol on carbohydrate and lipid metabolism in a rat model of Type II diabetes.
Topics: Adipocytes; Animals; Antioxidants; Blood Glucose; Body Weight; Diabetes Mellitus, Experimental; Diab | 1999 |
Review of management of type 2 diabetes mellitus.
Topics: Aged; Body Weight; Contraindications; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; | 1998 |
Safety and efficacy of metformin in a restricted formulary.
Topics: Blood Pressure; Body Weight; California; Diabetes Mellitus, Type 2; Female; Formularies, Hospital as | 1999 |
Metformin reverses fatty liver disease in obese, leptin-deficient mice.
Topics: Adenosine Triphosphate; Adipose Tissue; Animals; Body Weight; Energy Intake; Energy Metabolism; Fatt | 2000 |
Beneficial insulin-sensitizing and vascular effects of S15261 in the insulin-resistant JCR:LA-cp rat.
Topics: Animals; Blood Glucose; Body Weight; Chromans; Eating; Fluorenes; Gene Expression; Glucose Tolerance | 2000 |
Metformin reduces weight, centripetal obesity, insulin, leptin, and low-density lipoprotein cholesterol in nondiabetic, morbidly obese subjects with body mass index greater than 30.
Topics: Adult; Aged; Body Mass Index; Body Weight; Cholesterol, LDL; Coronary Disease; Fasting; Female; Huma | 2001 |
Mechanism of fat-induced hepatic gluconeogenesis: effect of metformin.
Topics: Administration, Oral; Alanine; Animals; Blood Glucose; Body Weight; Dietary Fats; Fatty Acids, Nones | 2001 |
Exercise adds to metformin and acarbose efficacy in db/db mice.
Topics: Acarbose; Animals; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Disease Models, Animal; Ea | 2001 |
Metformin in non-alcoholic steatohepatitis.
Topics: Adult; Alanine Transaminase; Body Mass Index; Body Weight; Fatty Liver; Female; Humans; Hypoglycemic | 2001 |
Biochemical and body weight changes with metformin in polycystic ovary syndrome.
Topics: Adult; Body Weight; Female; Humans; Hypoglycemic Agents; Insulin; Menstruation; Metformin; Obesity; | 2001 |
Metformin therapy throughout pregnancy reduces the development of gestational diabetes in women with polycystic ovary syndrome.
Topics: Adult; Blood Glucose; Body Weight; Cohort Studies; Diabetes Complications; Diabetes Mellitus; Diabet | 2002 |
Inhibition of gluconeogenesis by vanadium and metformin in kidney-cortex tubules isolated from control and diabetic rabbits.
Topics: Animals; Blood Glucose; Body Weight; Diabetes Mellitus; Gluconeogenesis; Hypoglycemic Agents; Kidney | 2002 |
Effects of combined pioglitazone and metformin on diabetes and obesity in Wistar fatty rats.
Topics: Adipose Tissue; Animals; Body Weight; Diabetes Mellitus; Drug Therapy, Combination; Eating; Glycogen | 2002 |
Treatment of type 2 diabetes mellitus in children and adolescents.
Topics: Adolescent; Black People; Blood Glucose; Body Weight; Child; Diabetes Mellitus, Type 2; Drug Therapy | 2002 |
Hypolipidemic effects of metformin in hyperprebetalipoproteinemia.
Topics: Adult; Blood Glucose; Body Weight; Cholesterol; Diabetes Complications; Female; Glucose Tolerance Te | 1976 |
Treatment of hypertriglyceridemia with metformin. Effectiveness and analỳsis of results.
Topics: Adult; Age Factors; Blood Glucose; Body Weight; Cholesterol; Drug Evaluation; Drug Resistance; Femal | 1977 |
Treatment of normal-weight diabetics.
Topics: Body Weight; Diabetes Mellitus; Diabetic Ketoacidosis; Humans; Metformin | 1978 |
Effects of metformin on glucose metabolism of isolated perfused rat skeletal muscle.
Topics: Adenosine Triphosphate; Animals; Body Weight; Creatine Kinase; Female; Glucose; Lactates; Metformin; | 1977 |
Treatment of normal-weight diabetics.
Topics: Aged; Body Weight; Diabetes Mellitus; Humans; Metformin; Middle Aged; Obesity | 1978 |
[Therapy of diabetes mellitus with oral drugs].
Topics: Acidosis; Body Weight; Diabetes Mellitus; Drug Tolerance; Humans; Metformin; Obesity; Sulfonylurea C | 1978 |
A comparison of phenformin and metformin in the treatment of maturity onset diabetes.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus; Dose-Response Relationship, Drug; Female | 1977 |
[Proinsulin and insulin secretion in obese females before and after administration of metformin].
Topics: Adult; Blood Glucose; Body Weight; Cholesterol; Diet, Reducing; Female; Glucose Tolerance Test; Huma | 1975 |
Influence of metformin on arginine-induced glucagon secretion in human diabetes.
Topics: Adult; Aged; Arginine; Blood Glucose; Body Weight; Diabetes Mellitus; Fatty Acids, Nonesterified; Fe | 1975 |
Subchronic treatment with metformin produces anorectic effect and reduces hyperinsulinemia in genetically obese Zucker rats.
Topics: Animals; Appetite Depressants; Blood Glucose; Body Weight; Corticosterone; Digestive System; Eating; | 1992 |
Mechanism of metformin action in obese and lean noninsulin-dependent diabetic subjects.
Topics: Blood Glucose; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Fasting; Female; Glucose; | 1991 |
A comparison of treatment with metformin and gliclazide in patients with non-insulin-dependent diabetes.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Gliclazide; Humans; Insu | 1988 |
Energy expenditure in non-insulin dependent diabetic subjects on metformin or sulphonylurea therapy.
Topics: Adult; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Energy Metabolism; Fatty Acids, Nonest | 1987 |
Anorectic effect of metformin in lean and genetically obese hyperglycaemic (ob/ob) mice.
Topics: Animals; Appetite Depressants; Blood Glucose; Body Weight; Eating; Injections, Intraperitoneal; Metf | 1986 |
Effect of metformin on peripheral insulin sensitivity in non insulin dependent diabetes mellitus.
Topics: Adult; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Hum | 1986 |
Dimethylbiguanide-evoked increase of anticoagulant elimination not associated with induction of drug metabolizing enzymes.
Topics: Aminopyrine N-Demethylase; Animals; Benzopyrenes; Body Weight; Carbon Radioisotopes; Chromatography, | 1974 |
Metformin administration in hyperlipidemic states.
Topics: Adult; Aged; Blood Glucose; Blood Protein Electrophoresis; Body Weight; Cholesterol; Electrophoresis | 1971 |
[Disturbance of intestinal absorption following metformin therapy (observations on the mode of action of biguanides].
Topics: Body Weight; Diabetes Mellitus; Humans; Intestinal Absorption; Lipids; Metformin; Obesity; Vitamin B | 1969 |
Observations on the mechanism of increased weight loss during metformin administration in obesity.
Topics: Body Weight; Carbohydrate Metabolism; Diet Therapy; Female; Humans; Lipid Metabolism; Metformin; Met | 1968 |
[Treatment of diabetes mellitus with metformin].
Topics: Adult; Aged; Body Weight; Chlorpropamide; Diabetes Mellitus; Drug Synergism; Female; Humans; Male; M | 1968 |
[On the clinical use of biguanides].
Topics: Aged; Biguanides; Blood Glucose; Body Weight; Cholesterol; Depression, Chemical; Diabetes Mellitus; | 1969 |
[Therapeutic possibilities in diabetes mellitus with biguanides. Clinical experiences in 122 diabetics with dimethylbiguanide(Glucophage)].
Topics: Adolescent; Adult; Biguanides; Body Weight; Chemical Phenomena; Chemistry; Diabetes Mellitus; Diet, | 1966 |